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FDA Picks Up The Pace
During his lamentably short stint as commissioner of the FDA, Mark McClellan set in motion a series of new, even bold, initiatives aimed at streamlining the drug review process. He quickly lit a fire under the agency – and by the time he was tapped to head the Centers for Medicare and Medicaid Services (CMS) in February 2004, the results of McClellan’s ambitious plans were already apparent.
For instance, in late 2002 the FDA approved Humira – a monoclonal antibody for treating rheumatoid arthritis developed by Cambridge Antibody Technology Group plc and Abbott Laboratories – in eight months, about two months earlier than expected, and without the need for an advisory committee meeting. And, in early 2003, Biogen Idec Inc.’s new psoriasis product Amevive also garnered the agency’s blessing ahead of schedule. As well, several drugs benefited from accelerated approvals in 2003 – including Trimeris Inc.’s AIDS drug Fuzeon, Millennium Pharmaceuticals Inc.’s myeloma drug Velcade and AstraZeneca plc’s lung cancer therapy Iressa.
All told, biotech and biotech-related product approval times in 2003 were considerably faster than they had been the previous year: The average approval time for all therapies (drugs plus biologics) was 20 months in 2003, as compared to 27 months in 2002. Plus, the FDA approved more biotech therapies in 2003 than in 2002 – 25 versus 15 -- implying that the efficiency of the drug review and approval process had improved.
After such a great start, then, it’s no wonder that the biotech and pharmaceutical sectors were deeply saddened – and discouraged – when McClellan abruptly departed the FDA for greener pastures. Would the FDA be able to stay the new course he had set without the benefit of his guidance? Or would it bog down again as it had during earlier leader-less eras?
Well, so far anyway, the fires lit by McClellan seem to be burning as brightly as ever. In 2004, the agency granted first-time approvals to 27 new biotech drugs and biologics, in additional to five medical devices and an in vivo diagnostic agent. That’s slightly better than 2003, when 25 new drugs and biologics were approved.
The average approval time for 2004’s new therapies was 16 months, significantly shorter than the average 20 month time frame in 2003 and vastly improved over the average approval time of 27 months that occurred in 2002. (We’ve included data from 1996 for comparison because it proved to be a high point in FDA’s history: In 1996, the agency approved 131 new drugs and eight biologics overall. Of those 139 products, 21 were sponsored by biotech firms.)
These data could certainly signify that the FDA’s reviewers have been able to keep up the pace set by McClellan. However, it’s important to note that a fair number of 2004’s new therapeutics were granted priority review status – meaning the agency must act on the application in six months – or accelerated approval status – meaning approval is granted based on surrogate endpoints and the sponsor must conduct a further clinical trial to establish the product’s clinical benefit.
For instance, three of the five new biologics were granted priority review: Avastin, Genentech Inc.’s anti-VEGF therapy for colorectal cancer (approved in five months); Kepivance, Amgen Inc.’s recombinant keratinocyte growth factor for treating oral mucositis in cancer patients (approved in 6 months); and Tysabri, Biogen Idec/Elan Corp. plc’s anti-integrin therapy for multiple sclerosis (approved in six months). (For rolling BLAs, the submission date used in these calculations is the date on which the submission was completed).
The other two biologics took much longer to wend their way through the regulatory process – ImClone Systems Inc.’s infamous colorectal cancer antibody Erbitux took 28 months from start to finish and Serono S.A.’s Luveris, a recombinant hormone for treating infertility, took 41 months to garner approval. Thus, the average approval time for 2004’s new biologics was 17.2 months – but even so, that average is significantly better than the average 24.8 months it took for 2003’s biologics to gain the regulatory go-ahead.
Several newly approved drugs also received priority status. For instance, Macugen, the anti-VEGF aptamer developed by Eyetech Pharmaceuticals Inc. and Pfizer Inc., was approved in six months for treating wet AMD. And the EGFR-inhibiting small molecule drug Tarceva, developed by OSI Pharmaceuticals Inc., Genentech and Roche, was approved in three months for treating advanced non-small cell lung cancer. Moreover, Sensipar, a small molecule calcimimetic drug developed by Amgen and NPS Pharmaceuticals Inc., was approved in six months for treating secondary hyperparathyroidism in kidney disease patients. (For rolling NDAs, the submission date used in these calculations is the date on which the submission was completed).
As well, a few new drugs were approved under accelerated review, including Genzyme Corp.’s nucleoside analog Clolar for treating childhood leukemia (nine months) and Gilead Sciences Inc.’s once-daily AIDS medication Truvada (five months).
Those speedy approval times helped balance a few exceptionally slow ones – like Elan’s severe pain drug Prialt, which took 60 months to make it through the drug approval process and Sepracor Inc.’s insomnia drug Lunesta, which took 23 months to garner approval. Thus, the average approval time for 2004’s new drugs was 15.7 months – and again, shorter than the average 17.6 months it took for a new drug to garner the FDA’s seal of approval in 2003.
The median approval times for 2004’s new therapies are impressive, too – especially for the biologics. As mentioned above, the fact that three of those products received priority review helped set the median approval time at six months – a far cry from any year in recent history. The median approval time for new drugs was 10 months – as it was in 2003 and in 2000.
Whether you favor averages or medians, though, the data are quite clear: 2004 was a great year for new product approvals in the biotech and specialty pharma sector, with many drugs and biologics flying through the review process in six months or less. Whether the FDA's reviewers will be able to keep up this torrid pace in 2005 remains to be seen.
originally published 01/07/2005 |