The Food and Drug Administration approved a raft of new drugs to close out 2015, pushing the total number of drugs approved last year north of 40. That doesn’t sound like a lot, but it’s actually pretty impressive. Since 1995, the FDA has only exceeded 2015’s approval count once, in 1996.
None of last year’s approvals are household names. Even the most promising drugs don’t earn widespread name recognition until they actually start appearing in medicine cabinets and hospital wards. That said, it’s a fair bet that at least a few of these innovative compounds will be on the tips of our tongues in the years to come. Some of the most intriguing include:
- Empliciti, Ninlaro, Darzalex: all indicated to treat various manifestations of multiple myeloma
- Genvoya: a new HIV treatment
- Tagrisso, Alecensa: indicated for non-small cell lung cancer treatment
- Vraylar, Aristada: indicated for schizophrenia and/or bipolar treatment and management
- Avycaz: indicated for complicated intra-abdominal and urinary tract infections
- Corlanor: indicated to minimize the need for hospitalization due to worsening heart failure
- Viberzi: indicated for specific manifestations of irritable bowel syndrome
All Well on the Drug Approval Front?
The rush of approvals last year masks some systemic problems with the FDA approval process, notes David DelCollo, an attorney specializing in healthcare law. A best-case FDA approval scenario follows a tortuous script that requires every step to shake out just so:
- Initial research into the properties and effects of promising compounds (time, money, high probability of error)
- Patent applications for the most promising compounds (time, money)
- New drug applications lodged with FDA review board (time, money, bureaucracy)
- Clinical study plan review (time)
- Three-phase clinical study over the course of three to seven years, sometimes longer (lots of time, lots of money, high probability of failure)
- The FDA reviews results and asks for clarification (time, money, bureaucracy, high probability of failure)
- Final FDA approval (time, bureaucracy, high probability of failure)
The evidence isn’t just anecdotal. Small startups headed by whip-smart scientists with great ideas simply can’t scrounge up the funds necessary to bring the compounds they’ve developed to market — or even get close. These companies have two choices: Find a strategic partner willing to pony up for a shot at a potentially huge payday, or sell their IP to a multinational pharmaceutical company with the resources to go the distance.
Neither is ideal. In fact, many small companies simply aren’t investing in new drug research at all. Even some of the bigger players are reallocating resources to more promising avenues — compounds that are much more likely to pan out, in niches that are much less competitive. That’s why so many of the FDA’s 2015 approvals are narrowly targeted drugs that treat rare or chronic conditions in very specific ways. The market for such drugs might not be big, but it’s captive — patients who need those drugs have no other choice but to pay up.
Where does the market for new drugs go from here? Unclear. 2016 will offer new clues — though, given the long lead times inherent in drug development, it’ll take several more years to get a bead on whether 2015 was a blip or a beginning.