The reduction in research and development for new molecular entities led the FDA to approve only six new molecular entities in the first quarter of the year. It was the lowest number of approvals in a single quarter since 2000 and three fewer than the same period last year, according to a report by Fitch Ratings.
Last year the FDA approved 27 drugs, slightly higher than the five-year average.
The biotechnology industry has been dealing with lower R&D productivity for years, even as investment has doubled as companies outsource research. A report by McKinsey that highlighted the issue a few years ago noted even then that NME approvals were in decline. But 2012 saw the most drug approvals in a decade and the FDA has been rolling out programs to help accelerate drug approvals.
Among the NMEs it did approve were Farxiga (dapaglifozin) tablets — a treatment to improve glycemic control, in adults with type 2 diabetes. It was developed by Bristol Myers-Squibb and AstraZeneca. It also gave the green light for a drug developed by Chelsea Therapeutics to manage neurogenic orthostatic hypotension– a rare, chronic and debilitating decline in blood pressure when patients stand up that’s associated with Parkinson’s disease and multiple-system atrophy, according to the FDA. It was fast-tracked as part of the accelerated approval program. Celgene’s psoriatric arthritis treatment also got approved.
The regulator also approved Amilyn Therapeutics’ replacement therapy Myalept to treat the complications of leptin deficiency. Lipodystrophy is a condition associated with a lack of fat tissue.
