|  |
Twelve New Biotech Therapies In 2001
It's been many years since therapeutically oriented biotechnology companies confined their drug-development efforts to recombinant proteins alone. While Amgen Inc.'s blockbusters Epogen and Neupogen (among others) remind us all that the profits from recombinant protein-based therapies can be handsome, indeed, the earnings potential of some small-molecule drugs -- take Lipitor or Prozac, for instance -- is irresistible.
In fact, biotech companies are often developing small molecules right alongside monoclonal antibodies or recombinant cytokines. That mix is clearly evident in the marketplace, too: The FDA approved 12 new therapeutics developed by biotech companies in 2001. Of those, six are biologicals (recombinant proteins, peptides or antibodies) and six are new chemical entities. (For details of these new products, see the table that follows.)
Biotech Company Drugs And Biologics Approved By The FDA In 2001 (First-Time Approvals Only)
|
Product Name
(Active Ingredient)
|
Company (s)
(Developer, Marketer)
|
Product Description
|
Indication
|
Approval
Date
|
|
Aranesp
(darbepoietin alfa)
|
Amgen, Kirin
|
Novel erythropoiesis-stimulating protein
(2nd generation EPO; longer-lasting)
|
Treatment of anemia in patients with chronic renal insufficiency and
chronic renal failure (+/- dialysis)
|
9/01
|
|
Arestin
(minocycline HCl microspheres)
|
OraPharma
|
Doxycycline in biodegradable gel
|
Adjunctive treatment of periodontal disease in adults
(local administration)
|
2/01
|
|
Campath
(alemtuzumab)
|
Millennium Pharmaceuticals (LeukoSite), Ilex Oncology, Berlex Laboratories
(Schering AG)
|
Humanized monoclonal antibody against CD52 antigen on T and B cells
|
B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been
treated with alkylating agents and who have failed fludabarine therapy
|
5/01
|
|
Digifab
(digoxin immune Fab [ovine])
|
Protherics
|
Digoxin-immune ovine Fab [fragment antigen-binding] (monovalent) immunoglobulin
fragments (obtained from blood of sheep immunized with a digoxin derivitive)
|
Treatment for digoxin toxicity
(digoxin prescribed for various heart conditions)
|
8/01
|
|
Focalin
(formerly Attenade)
(dexmethyl-phenidate HCl)
|
Celgene, Novartis Pharmaceuticals
|
Chirally pure version of ritalin; contains only the more active isomer
|
Attention deficit hyperactivity disorder
|
11/01
|
|
Frova
(frovatriptan succinate)
|
Vernalis Group, Elan Pharmaceuticals
|
Small molecule that binds to and stimulates serotonin (5HT1B/1D) receptors
(partial agonist)
|
Acute treatment of migraine attacks in adults
(pill)
|
11/01
|
|
Kineret
(anakinra)
(formerly Antril, Synergen)
|
Amgen
|
Recombinant interleukin-1 receptor antagonist
|
Reduction in signs and symptoms of moderately to severely active rheumatoid
arthritis in adults who have failed one or more disease modifying antirheumatic
drugs
(DMARDS)
|
11/01
|
|
Metadate CD
(methylphenidate HCl)
|
Celltech Pharmaceuticals
(Medeva Pharmaceuticals)
|
Once-daily, biphasic formulation of methylphenidate
|
Attention deficit hyperactivity disorder in patients 6 years of age and
older
(extended release capsules)
|
4/01
|
|
Natrecor
(nesiritide)
|
Scios, Innovex
|
Recombinant B-type natriuretic peptide
|
Acute decompensated congestive heart failure
|
8/01
|
|
Peg-Intron
(peginterferon alfa-2b)
|
Enzon, Schering-Plough
|
Recombinant interferon alfa-2b modified with polyethylene glycol (PEG)
to give it longer-acting properties
|
Chronic hepatitis C virus infection in patients 18 years or older with
compensated liver disease who have not been previously treated with IFN-a
|
1/01
|
|
Tracleer
(bosentan)
|
Actelion, Genentech
|
Dual endothelin receptor antagonist (orally active)
|
To improve exercise ability and decrease the rate of clinical worsening
in patients with pulmonary arterial hypertension (pill)
|
11/01
|
|
Viread
(tenofovir disoproxil fumarate)
|
Gilead Sciences
|
Nucleotide analog reverse transcriptase inhibitor
|
HIV infection; combination with existing antiviral regimens; also for
use in resistant patients; i.e., for use in all AIDS patients
(once-daily dosing)
|
10/01
|
Twelve first-time approvals in one year isn't a bad record -- especially considering that several of these products (Aranesp, Kineret, PEG-Intron and Viread) seem destined for the big leagues. Yet, the FDA approved more new biotech medicines in 2000 -- 16 of them -- than it did in 2001. (For a list of FDA approvals in 2000, please refer to the Signals article, "New Biotech Medicines: 16 Approved And 19 In The Queue.")
In the greater scheme of things, biotech companies' therapeutic products constituted about one-third of all new medicines approved by the FDA last year. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the agency approved a total of 32 new medicines in 2001. Of those, 24 were classed as drugs and eight as biologics.
According to PhRMA's list, the biologics include: Amgen's second-generation EPO Aranesp and rheumatoid arthritis therapy Kineret; Ilex Oncology Inc.'s leukemia treatment Campath; Protherics plc's anti-digoxin product Digifab; Enzon Inc.'s long-acting hepatitis C virus therapy PEG-Intron; and NABI's hepatitis B virus treatment Nabi-HB. This last product, however, has been on the market for several years already. In 2001, the company received approval for Nabi-HB produced in its own manufacturing facility.
Big pharma's got two products on the biologics list, too: Eli Lilly and Co.'s important new severe sepsis drug, Xigris, is a recombinant version of human activated protein C; GlaxoSmithKline Biologicals' hepatitis A/hepatitis B virus vaccine, TwinRix, consists of a recombinant subunit hepatitis B vaccine and an inactivated hepatitis A vaccine.
Biotech Company Products Under FDA Review
|
Product Name
(Active Ingredient)
|
Company (s)
(Developer, Marketer)
|
Product Description
|
Indication
(Sought)
|
Submission Type
(Date)
|
Review Status, Details, Comments
|
|
Anogesic
(nitroglycerin ointment)
|
Cellegy Pharmaceuticals
|
Nitroglycerin ointment
|
Treatment of pain associated with chronic anal fissures
|
NDA
(6/01)
|
Submitted supplement that includes data from recently completed Phase
III trial (12/01)
|
|
Anti-hepatitis B hyperimmune product
|
Cangene
|
Highly purified polyclonal antibodies to HBV made from human plasma
|
Post-exposure prevention of hepatitis B virus infection
|
BLA
(9/01)
|
-----
|
|
Aranesp
(darbepoietin alfa)
|
Amgen, Kirin
|
Novel erythropoiesis-stimulating protein (2nd generation EPO; longer-lasting)
|
Treatment of anemia in cancer patients undergoing chemotherapy
|
Supplemental BLA
(9/01)
|
Initially approved 9/01 (treatment of anemia in patients with chronic
renal insufficiency and chronic renal failure [+/- dialysis])
|
|
Argatroban
(a.k.a. Acova)
|
Texas Biotechnology, GlaxoSmithKline
|
Anticoagulant; synthetic small molecule derived from arginine; direct
thrombin inhibitor
|
Use in patients who have or are at risk of developing thrombosis associated
with heparin-induced thrombocytopenia (HIT) and are undergoing percutaneous
coronary intervention (PCI)
|
Supplemental NDA
(12/00)
|
Initially approved 6/00 (prevention or treatment of thrombosis in patients
with HIT); FDA issued approvable letter (7/01)
|
|
Aslera
(formerly GL701)
(prasterone)
|
Genelabs Technologies, Watson Pharmaceuticals
|
Adrenal hormone (dehydroepiandrosterone [DHEA])
|
Systemic lupus erythematosus
|
NDA
(modular)
(5/00-9/00)
|
Athritis Advisory Committee split on drug's benefits and did not vote
(4/01); FDA issued non- approvable letter (6/01)
|
|
Bexxar
(tositumomab, iodine I 131)
|
Corixa (Coulter Pharmaceutical), GlaxoSmithKline
|
Murine monoclonal antibody against CD20 antigen on B cells, conjugated
to I-131
|
Patients with relapsed or refractory low-grade or transformed low-grade
B-cell non-Hodgkin's lymphoma
|
BLA
(7/99);
BLA
resubmission
(9/00)
|
In complete review letter (3/01), FDA requested additional clinical and
manufacturing information, which company submitted (8/01, 9/01); As of
1/02, FDA had not reviewed all this material; Advisory Committee review
will not occur 2/02, may occur 6/02
|
|
Ceplene
(formerly Maxamine; histamine dihydrochloride)
|
Maxim Pharmaceuticals
|
H2 receptor agonist
|
Adjuvant to interleukin-2 for treating patients with advanced metastatic
melanoma with liver metastases
|
NDA
(7/00)
|
FDA issued non-approvable letter (1/01)
|
|
Cialis
|
Lilly ICOS LLC (Icos Lilly joint venture)
|
PDE5 (phosphodiesterase) inhibitor
|
Erectile dysfunction
|
NDA
(6/01)
|
NDA accepted for review (8/01)
|
|
Dynepo
(gene-activated EPO)
|
Transkaryotic Therapies, Aventis Pharma
|
Human erythropoietin produced via gene activation (inserts DNA sequences
into human cells, thus activating the endogenous human gene to stimulate
EPO production)
|
Anemia in patients with chronic renal failure (both dialysis and non-dialysis
patients)
|
BLA
(8/00)
|
FDA did not accept BLA for filing; it requested data on additional manufacturing
runs of Dynepo (due to change in manufacturing process); amount of new
data means they will be submitted as part of a new BLA (11/00)
|
|
Enbrel
(etanercept)
|
Immunex, Wyeth-Ayerst Laboratories (American Home Products)
|
Dimeric fusion protein; recombinant soluble p75 tumor necrosis factor
receptor (TNFr) linked to Fc portion of human IgG1
|
Psoriatic arthritis
(+/- methotrexate)
|
Supplemental BLA
(7/01)
|
Initially approved 11/98 (moderate-to-severe active rheumatoid arthritis);
approved for marketing (1/02)
|
|
Erbitux
(IMC-C225)
|
ImClone Systems, Bristol-Myers Squibb
|
Chimeric monoclonal antibody to epidermal growth factor receptor (EGFr)
|
Combination with irinotecan (chemotherapy) to treat irinotecan-refractory
colorectal cancer that is positive for EGFr
|
BLA
(rolling)
(6/01-10/01)
|
FDA issued a refusal-to-file letter, citing incomplete trail of documentation
and other factors (12/01)
|
|
Estrasorb
(17-beta-estradiol)
|
Novavax, King Pharmaceuticals
|
Uses micellar nanoparticles to deliver natural hormone 17-beta-estradiol
through the skin (cream)
|
Topical estrogen replacement therapy for symptomatic menopausal women
|
NDA
(6/01)
|
NDA accepted for review (9/01)
|
Of the 24 drugs on PhRMA's list, four were developed by biotech companies. These include Frova, a serotonin receptor agonist for treating migraine attacks developed by the Vernalis Group plc; Natrecor, Scios Inc.'s compound for acute congestive heart failure (which, incidentally, is a recombinant peptide, not a synthetic); Tracleer, Actelion Ltd.'s orally active endothelin receptor antagonist for treating patients with pulmonary arterial hypertension; and Viread, Gilead Sciences Inc.'s nucleotide analog reverse transcriptase inhibitor for HIV infection.
Three more biotech-sponsored drugs approved in 2001 were not on the PhRMA's list. These drugs, modified formulations of existing products, include OraPharma Inc.'s periodontal disease product Arestin and two drugs for treating attention deficit hyperactivity disorder -- Celgene Corp.'s Focalin and Celltech Pharmaceuticals' Metadate CD. (See the table for details.)
And, though it isn't a biotech company, Novartis AG employed state-of-the-art rational drug design to create its oral cancer drug Gleevec, a signal transduction inhibitor. In chronic myeloid leukemia, Gleevec blocks the function of the Bcr-Abl protein (which causes uncontrolled proliferation of white blood cells). Gleevec's not the first rationally designed drug to garner FDA approval: Two HIV protease inhibitors (Agouron Pharmaceuticals Inc.'s Viracept and Vertex Pharmaceuticals Inc.'s Agenerase) and two neuraminidase inhibitors for treating flu (Gilead Sciences' Tamiflu and Biota Holdings Ltd.'s Relenza) preceded it. But Gleevec is the first oncology drug to be created this way. And it’s the first in a class of compounds that interfere with tyrosine kinases -- enzymes long though to be the key targets for new therapies against a wide variety of diseases.
In 2001, the following biotech medicines -- each already on the market for at least one indication -- garnered further approval:
§ Cathflo Activase. Genentech Inc.'s well-known clot-buster Activase, recombinant tissue plasminogen activator, was approved in September to restore function to central venous access devices (catheters) that have become occluded or blocked. The FDA first approved Activase in November 1987, for treating acute myocardial infarction.
§ PEG-Intron plus Rebetol. In August, the FDA approved Enzon and Schering-Plough Corp.'s PEGylated recombinant interferon alfa-2b, used together with Rebetol (ribavirin), as a combination therapy for treating hepatitis C virus infection. The agency had approved PEG-Intron as a monotherapy in January (see above).
§ Remicade. This monoclonal antibody to tumor necrosis factor-alpha, developed by Centocor Inc. (a Johnson & Johnson company) got a big boost in January, when the FDA approved its use as a combination therapy with methotrexate for treating rheumatoid arthritis. The agency first approved Remicade in August 1998 for treating Crohn's disease.
§ Rituxan. In May, the FDA approved a retreatment regimen for Rituxan, allowing physicians to continue initial therapy for longer periods of time or to administer multiple therapies. Rituxan, an anti-CD20 monoclonal antibody that targets B cells, was developed by Idec Pharmaceuticals Corp. and Genentech; it was first approved in November 1997 for treating relapsed or refractory non-Hodgkin's lymphoma.
§ Visudyne. QLT Inc.'s photodynamic therapy was approved in August for treating subfoveal choroidal neovascularization due to pathologic myopia and presumed ocular histoplasmosis. The FDA first approved the therapy in April 2000 for treating wet age-related macular degeneration.
Biotech Company Products Under FDA Review
|
Product Name
(Active Ingredient)
|
Company (s)
(Developer, Marketer)
|
Product Description
|
Indication
(Sought)
|
Submission Type
(Date)
|
Review Status, Details, Comments
|
|
Fabrazyme
(agalsidase beta)
|
Genzyme
|
Recombinant human alpha-galactosidase A
|
Enzyme replacement therapy for patients with Fabry disease
|
BLA
(6/00)
|
FDA issued complete response letter; wants more information (10/01)
|
|
FluMist
|
Aviron, Wyeth-Lederle Vaccines (American Home Products)
|
Attenuated, cold-adapted live virus vaccine (intranasal)
|
To prevent influenza in children and adults
|
BLA
(10/00)
|
Vaccines and Related Biological Products Advisory Committee said product
is efficacious but not convinced of safety, needs more data (7/01); FDA
issued complete response letter (8/01); company submitted the requested
additional information and clarification on clinical and manufacturing
data (1/02)
|
|
Gliadel Wafer
(polifeprosan 20 with carmustine implant)
|
Guilford Pharmaceuticals (reacquired marketing rights from Aventis Pharma
in 10/00)
|
Biodegradable polyanhydride wafer containing carmustine (implant)
|
First-line therapy for patients with newly diagnosed glioma
|
Supplemental NDA
(4/01)
|
Initially approved 9/96 (2nd-line therapy for recurrent glioblastoma
multiforme); Oncologic Drugs Advisory Committee voted 8-5 that product
provides clinical benefit with acceptable safety (12/01)
|
|
Imavist
(formerly Imagent; AF0150)
|
Alliance Pharmaceutical, Schering AG
|
Ultrasound contrast agent (perfluorohexane-based)
|
Intravenous contrast agent for enhancement of ultrasound images to assess
cardiac structure and function and to detect organ lesions and blood flow
abnormalities
|
NDA
(10/99)
|
FDA issued approvable letter (8/00); company submitted documentation
in response (8/01)
|
|
IntraDose
Injectable Gel
|
Matrix Pharmaceutical
|
Cisplatin and epinephrine in a protein matrix
|
Recurrent or refractory head and neck cancer (direct injection into tumor)
|
NDA
(1/01)
|
Oncologic Drugs Advisory Committee declined to vote on approval; not
enough evidence as to safety and efficacy (9/01); FDA issued non-approvable
letter (11/01)
|
|
Leuprogel
One-Month Depot
(leuprolide acetate)
|
Atrix Laboratories, Sanofi-Synthelabo
|
Sustained release of leuprolide via Atrigel Depot drug delivery system
|
Advanced prostate cancer
|
NDA
(3/01)
|
------
|
|
Leuprogel
Three-Month Depot
(leuprolide acetate)
|
Atrix Laboratories, Sanofi-Synthelabo, MediGene
|
Sustained release of leuprolide via Atrigel Depot drug delivery system
|
Advanced prostate cancer
|
NDA
(9/01)
|
----
|
|
LeuTech
|
Palatin Technologies, Mallinckrodt
|
Radiolabeled monoclonal antibody that binds specifically to white blood
cells; for in vivo imaging of infection sites
|
Diagnosis of appendicitis in patients with equivocal signs and symptoms
|
BLA
(11/99)
|
Medical Imaging Drugs Advisory Committee voted to recommend approval
(7/00); FDA asked for more manufacturing data (9/00); company will file
BLA amendment in "latter part" of 2002 (10/01)
|
|
Metvix
|
PhotoCure
|
Photodynamic therapy (cream formulation together with CureLight lamp)
|
Actinic keratosis (pre-cancerous skin lesions)
|
NDA
(9/01)
|
------
|
|
Paclitaxel
|
NaPro BioTherapeutics, Abbott Laboratories
|
Generic paclitaxel; inhibits cell division by blocking microtubule assembly/dis-assembly;
extracted from needles and limb stock of ornamental yew trees
|
Cancer
|
Abbreviated NDA
(3/01)
|
----
|
|
Peg-Intron Redipen
|
Enzon, Schering-Plough
|
Recombinant interferon alfa-2b modified with polyethylene glycol (PEG)
to give it longer-acting properties
|
Chronic hepatitis C virus infection; single dose delivery system
|
Supplemental BLA
(7/01)
|
----
|
|
Picovir
(pleconaril)
|
ViroPharma, Aventis Pharmaceuticals
|
Small molecule antiviral; inhibits function of picornavirus capsid (essential
for infectivity and transmission)
|
Viral respiratory infection (the common cold) in adults; oral dose
|
NDA
(7/01)
|
NDA accepted for filing (10/01)
|
As well, biotech firms involved in developing medical devices and in vitro diagnostics scored more than a handful of first-time approvals in 2001. These include the following:
§ Dermagraft. Advanced Tissue Sciences Inc. worked long and hard to get this product approved. It took the FDA nearly five years to approve Dermagraft, a human tissue-engineered replacement for the dermal layer of the skin, for use in healing diabetic foot ulcers.
§ OrCel. Ortec International Inc.'s biologically active cellular matrix (which contains epidermal and dermal cells in a collagen base) was approved for healing donor site wounds in burn victims and granted Humanitarian Device Exemption status for use in epidermolysis bullosa patients requiring hand reconstruction.
§ FortaGen Surgical Mesh, FortaFlex Surgical Sling, and PuraPly. These three devices, developed by Organogenesis Inc., consist of a bioengineered type I collagen matrix that's used in tissue repair. The Mesh is approved for reinforcing soft tissue; the Sling is used for supporting soft tissue where weakness exists; and PuraPly is used as a wound dressing.
§ Gynecare Intergel. Lifecore Biomedical Inc.'s product, composed of hylauronic acid, was approved to reduce post-surgical adhesion formation in women after gynecological procedures.
§ Shellgel and Staarvisc II. Hyaluronic acid forms the basis of these viscoelastic products, also. Developed by Anika Therapeutics Inc., both products are used in ophthalmic surgery.
§ GlucoWatch Biographer. Cygnus Inc.'s non-invasive device collects glucose through the skin to automatically monitor glucose levels in diabetics.
§ OP-1 Implant. Curis Inc.'s bone graft substitute (which consists of recombinant human osteogenic protein-1 in a collagen matrix) was granted Humanitarian Device Exemption status for treating non-union fractures of the tibia.
§ TruGene HIV-1 Genotyping Kit. Visible Genetics Inc.'s HIV genotyping and DNA sequencing diagnostic is the first pharmacogenomics-based HIV test kit. It decodes HIV-1 from a patient's serum and then identifies the mutations in the virus, allowing physicians to prescribe a personalized treatment regimen.
Although we grumble about the slow-down in review times, the FDA's heightened sensitivity to safety issues and its seemingly permanent lack of a commissioner, there's no question that the agency put its stamp of approval on some very important new medicines in 2001. These certainly include Aranesp, Kineret, PEG-Intron (especially when combined with Rebetol), Viread, Xigris and Gleevec. Moreover, best-sellers Remicade and Rituxan have found new, expanded, markets.
And there's more to come. At the turn of the year, there were a total of 11 biologics license applications (BLAs), 15 new drug applications (NDAs), one premarket approval application (PMA) and eight supplemental applications pending at the FDA. Some of these have already been reviewed by the agency (or one of its advisory committees) once, and found lacking for one reason or another. Company sponsors are even now striving to provide the proper documentation to satisfy the FDA and its reviewers. Other applications are newly arrived. (For details, refer to the tables scattered throughout this article.)
Biotech Company Products Under FDA Review
|
Product Name
(Active Ingredient)
|
Company (s)
(Developer, Marketer)
|
Product Description
|
Indication
(Sought)
|
Submission Type
(Date)
|
Review Status, Details, Comments
|
|
Plenaxis
(formerly Abarelix Depot)
|
Praecis Pharmaceuticals, Sanofi-Synthelabo
|
Synthetic peptide that acts as a gonadotropin-releasing hormone antagonist
|
Hormonally responsive prostate cancer
|
NDA
(12/00)
|
FDA said NDA is inadequate for approval (6/01);
company now conducting more clinical trials (12/01)
|
|
PolyHeme
|
Northfield Laboratories
|
Chemically modified hemoglobin derived from outdated donor blood
|
Oxygen-carrying blood substitute for trauma situations
|
BLA
(8/01)
|
FDA issued a refusal-to-file letter (seeks additional information) (11/01)
|
|
Rebif
(interferon
beta-1a)
|
Serono
|
Recombinant interferon beta-1a
|
Relapsing remitting multiple sclerosis
|
Supplemental BLA
(3Q:01)
|
Original BLA filed 2/98
|
|
Relenza
(zanamivir)
|
Biota Holdings, Glaxo Wellcome
|
Neuraminidase inhibitor
|
Prevention of influenza A and B in adults
|
Supplemental NDA
(9/00)
|
Initially approved 7/99 (treatment of influenza A and B in adults and
children 12 years of age and older)
|
|
Remodulin (formerly Uniprost, a.k.a., UT-15)
(treprostinil sodium)
|
United Therapeutics
|
Analog of natural molecule prostacyclin
|
Pulmonary arterial hypertension (subcutaneous)
|
NDA (modular)
(8/00-10/00)
|
Cardiovascular and Renal Drugs Advisory Committee recommended approval
(8/01)
|
|
Replagel
(agalsidase alfa)
|
Transkaryotic Therapies, Sumitomo Pharmaceuticals
|
Alpha galactosidase A
|
Enzyme replacement therapy for Fabry disease
|
BLA
(6/00)
|
FDA issued complete review letter, requesting clarification and additional
data (1/01)
|
|
RhBMP-2/ACS
|
Genetics Institute, Wyeth-Ayerst Laboratories (American Home Products)
|
Recombinant version of human bone morphogenic protein-2 applied to an
absorbable collagen sponge matrix
|
Treatment of acute long-bone fractures requiring open surgical management
|
PMA
(12/00)
|
FDA issued non-approvable letter (6/01)
|
|
Symlin
(pramlintide acetate)
|
Amylin Pharmaceuticals
|
Synthetic version of human hormone amylin
|
Adjunctive therapy to insulin for treating people with Type I or II diabetes
who use insulin
|
NDA
(12/00)
|
Endocrinologic and Metabolic Drugs Advisory Committee voted not to recommend
approval; safety concerns (7/01); despite that, FDA issued approvable
letter, but called for additional clinical work prior to approval (10//01)
|
|
Vevesca
(OGT 918)
|
Oxford GlycoSciences
|
Small molecule inhibitor of glycosyltrans-ferase (inhibits glycolipid
formation)
|
Type I Gaucher disease (oral administration)
|
NDA
(rolling)
(3/01-8/01)
|
NDA accepted for filing (10/01)
|
|
Xolair
(a.k.a. Anti-IgE; rhuMAb-E25; omalizumab)
|
Genentech, Tanox, Novartis
|
Recombinant humanized anti-IgE monoclonal antibody
|
Allergic asthma and seasonal allergic rhinitis
|
BLA
(6/00)
|
FDA issued complete response letter, requesting more data (7/01); companies
plan to submit amendment to BLA 4Q:02
|
|
Zevalin
(ibritumomab tiuxetan)
|
Idec Pharmaceuticals, Schering AG
|
Murine monoclonal antibody that targets CD20 antigen on B cell surface,
conjugated to yttrium-90 (used in conjunction with rituximab)
|
Radioimmunotherapy for treating low grade or follicular, relapsed or
refractory, CD20-positive, B-cell non-Hodgkin's lymphoma and rituximab-refractory
follicular NHL
|
BLA
(11/00)
|
Oncologic Drugs Advisory Committee recommended approval in Rituxan-refractory
NHL, and accelerated approval in Rituxan-naïve patients (9/01); FDA issued
complete review letter; certain manufacturing compliance issues at fill/finish
group Catalytica need to be resolved prior to approval (1/02)
|
The FDA's gotten off to a good start in 2002: In early January, Immunex Corp.'s rising star -- arthritis drug Enbrel -- gained further marketing clout as a therapy for psoriatic arthritis. Then, on the last day of January, Amgen announced it had received marketing approval for its next-generation, PEGylated Neupogen, called Neulasta, for decreasing the incidence of infection in cancer patients receiving chemotherapy.
Moreover, on February 1, Novartis' Gleevec garnered its second approval -- for treating patients with inoperable and/or metastatic malignant gastrointestinal stromal tumors (GISTs). In this instance, Gleevec apparently targets the tyrosine kinase c-kit, which is thought to drive the growth and division of most GISTs.
And among the medicines now waiting for approval lie a few more potential blockbusters --- including the allergy medication Xolair, being developed by Genentech, Tanox Inc. and Novartis and the erectile dysfunction drug Cialis being developed by Lilly ICOS LLC.
It could be a great year.
originally published 02/01/2002 |