Should Old Acquaintance Be Forgot
It's no secret that the FDA prefers new applications of known, approved drugs. A longer clinical history is perhaps the most valuable asset a "new" drug (or device or biologic) can have—it certainly helps with the safety part of the application. Except, of course, when that clinical history is bad news.
Consider Orexigen's Contrave (naltrexone + bupropion), which recently received a positive review from the FDA's expert panel (though they still advised more cardiovascular monitoring). Its competitors, Vivus' Qnexa (phentermine + topiramate) and Arena's lorcaserin, were refused approval earlier this year for lack of safety and efficacy data.
Breaking down the compounds, Contrave is made up of two drugs already in use for several years in treating addiction; Qnexa has the misfortune of containing phentermine, a stimulant that was half of the infamous "Fen-Phen" combo; and lorcaserin is both a new molecular entity and also structurally similar to fenfluramine (the "Fen" part of the duo).
Cleaning up for 2011, the FDA also withdrew approval for weight-loss drug Meridia (sibutramine, related to the other amines) after 13 years on the market.
As a result of the October withdrawal of Meridia, there is only one FDA-approved long-term weight-loss drug: Orlistat. Its loneliness at the top, combined with its embarrassing side effects and potential liver problems, give the FDA a very strong motive to tilt the scales toward approval of another anti-obesity drug, even when some of the efficacy benchmarks remain unfulfilled.
It's also been a bad year for personalized genetic testing. From being a $30 over-the-counter deal in Walgreens to qualifying as a "medical device" for the purposes of regulation, the appearance and disappearance of consumer genetic testing served as an excellent example of how much regulatory guidance is needed for a nascent field such as this.
On the flip side, rapid HIV tests, HIV drugs, and anticancer drugs have benefited from being pioneers in enormously hurting fields. Mylotarg (an antibody for treating acute myeloid leukemia) was granted accelerated approval in 2000. It was, however, pulled from the market in June after continued studies found no significant benefit to taking the drug.Similarly mAb therapeutic Avastin lost its breast cancer approval last year; it's a bad day for antibodies.
Clearly, being too new is a liability as well, even when playing by the FDA's rules. Provenge, the innovative anticancer vaccine approved this year, received an initial refusal on its first run through the approval gauntlet. Clearly, the ideal product has a long, clean clinical record combined with a novel application in the FDA's latest field of interest; so how does that relate to 2011?