Cautious year for FDA yields few blockbusters
The FDA stretched out the timing of approvals last year as the safety concerns made it increasingly hard to take a yes-no stand on pipeline drugs. Of those drugs that were approved, sales projections have been largely disappointing.
The FDA's delay of AstraZeneca's antiplatelet drug Brilinta in December, despite strong clinical evidence in its favor, was emblematic of the agency's propensity for extra caution. No additional studies were asked for in a Dec. 16 complete response letter (CRL), leaving analysts to puzzle over the reasoning.
Earlier in the month, Human Genome Sciences and Glaxo-SmithKline saw the agency put a hold on their lupus drug Benlysta, delaying a decision until March. Here, the FDA did not issue a CRL but requested additional information from HGSI.
The cautious mentality manifested in October, as well, first when Eli Lilly and Amylin received a CRL for diabetes drug Bydureon. The once-weekly GLP-1 was intended as a new and improved version of currently marketed Byetta, a twice-weekly GLP-1. The CRL, Bydureon's second, asked the companies to conduct a new study of cardiac conduction abnormalities, pushing out approval to at least 2012. Arena/Eisai's lorcaserin and Vivus' Qnexa weight-loss compounds also bore the brunt of a more careful FDA. Both received CRLs in October following negative advisory panel reviews.
On the other hand: “It does seem like in certain therapeutic areas, things have been better,” said Ben Weintraub, PhD, director of research, Wolters Kluwer inThought.
One of these areas was multiple sclerosis. Gilenya, the oral MS therapeutic from Novartis, was approved without much hassle, as was Elan and Acorda Therapeutics' own MS drug, Ampyra.
With 10 business days left in the year, the agency was closing in on totals for 2009, when 19 NMEs and 6 BLAs were cleared by the FDA's Center for Drug Evaluation and Research—one more than in 2008. With some exceptions (Novo Nordisk's diabetes med Victoza, for instance), these have overall been disappointing in terms of sales forecasts. Why so few blockbusters in 2010, as well as in the last few years?
As with Dendreon's Provenge, the prostate cancer therapeutic vaccine approved in April, manufacturing capacity is to blame.
In the case of Amgen's Prolia, approved in June for osteoporosis and later as Xgeva for cancer, the drug has seen slow uptake largely because it's “going up against established prescribing trends,” said Weintraub. Doctors are being asked to adapt a twice-yearly injection instead of a weekly pill.
Another reason is the innovation gap. “We haven't had a lot of drugs the last few years that are truly new mechanisms of action,” he added. “In cardiology and diabetes, we've had some great successes and the disease is managed pretty well, so anything that comes along now will be used in a sub-population that's not well served.”
Something like Merck's anacetrapib, which raises HDL, could be blockbuster, as could Bydureon. Ditto for BMS's ipilimumab and Roche/Plexxikon's PLX-4032 melanoma drugs. “Things are coming,” concluded Weintraub. “I don't think the pharma and biotech industry are running out of ideas.”