Last year was another lackluster one for the drug and biotech industries, as the FDA seemed to ratchet-up its scrutiny of trial data and set the bar higher on requirements for drug efficacy. Overall, the regulatory agency approved 24 new drugs in 2010, which was slightly down from the 26 it approved in 2009 and dead-even with the 24 it approved in 2008. Only 17 were approved by the FDA in 2007
Two of the newly approved drugs appear to have a shot at becoming blockbusters: these are Gilenya, which is Novartis’ pill for multiple sclerosis, and Provenge, Dendreon’s injectable treatment for advanced prostate cancer. A pair of much-anticipated obesity drugs, Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa were rejected by the FDA, as were many others. Perhaps the biggest news however, focused on the FDA’s handling of safety issues surrounding drugs it had approved in previous years. Here’s a summary of some winners and losers:
Newly Approved Drugs
Multiple Sclerosis-Patients with multiple sclerosis did have a good deal to cheer about last year. In addition to Gilenya, the FDA approved Ampyra (Acorda Therapeutics) to improve gait disturbances in MS patients.
Advanced Prostate Cancer-Dendreon finally won FDA approval for its cancer-fighting vaccine, Provenge. The regulatory agency had previously rejected the drug and required that additional trials be performed, despite early clinical trials which were generally positive.
Stroke Prevention-Drug makers have been vying for years to replace warfarin, the widely used anticoagulant that has been available for more than half a century. After receiving approval for its drug, Pradaxa to prevent stroke in patients with cardiac arrhythmias, Boehringer Ingelheim now has a head start in this highly lucrative field.
Emergency Contraception-HRA Pharma’s drug ella, was approved by the FDA last summer. It blocks pregnancy up to five days after sexual intercourse, a full-day longer than other drugs on the market. The drug is now marketed in the US by Watson Pharmaceuticals.
Stroke Prevention-The FDA asked AstraZeneca for more information from a generally positive study of the anticoagulant, Brilinta assuring a longer glide path to market for Boehringer’s entry into this space (see above).
Lupus-Similarly, the agency announced it wanted more time to study trial results regarding Benlysta, a much anticipated lupus drug produced by Human Genome Sciences and GlaxoSmithKline.
Newly Restricted or Removed
Diabetes-In arguably its biggest call of the year, the FDA sharply curtailed utilization of Avandia, GlaxoSmithKline’s diabetes drug after post-market surveillance studies linked it to an increased risk of heart attacks.
Obesity-It was truly a dismal year for drug companies hoping to cash-in on the global obesity pandemic. In addition to rejecting the new drug applications for lorcaserin and Qnexa, the FDA removed Abbott’s Meridia from the market, because its relatively low efficacy didn’t justify its tendency to increase cardiac risk.
Pain Management-The makers of Darvon and Darvocet decided to pull these drugs from the market as well, in this case because of longstanding concerns that they provoked cardiac arrhythmias.
Breast Cancer-Just before year-end, the FDA announced it planned to revoke the approval it had given to Roche’s Avastin for the treatment of breast cancer, because the drug didn’t improve life expectancy and was associated with venous thromboembolism. The move won’t affect other FDA-approved uses of the drug. Roche is appealing the decision.