The FDA approved 26 new drugs last year, edging out the 25 approvals for first-of-a-kind therapies in 2008, according to analysts at Washington Analysis. But biotechnology emerges as the real winner in the annual statistical review. Of the 26 new drug approvals in 2009, seven were for biotech therapies. That compares to four new biotech drugs in 2008 and two new sanctions in 2007.
The Wall Street Journal asked Ira Loss, a senior health policy analyst at Washington Analysis, whether the spike represents a watershed of sorts for biotech drugs versus the small-molecule drug field. But he was a tad skeptical.
"I think it has the potential to be a breakout," he responded, "but I am not prepared to say so based on one year. If there is a repeat performance in 2010 then I would be prepared to say the long awaited breakthrough in therapeutic biotech approvals may in fact be here. But not yet!"
The slow pace of drug approvals overall has bedeviled the biopharma industry for years. But with the Obama administration dedicating more money to the FDA, it's quite possible that the routine breach of PDUFA deadlines can be rectified. With fewer regulatory delays at the agency, more approvals are almost a sure thing. That would be a big boon for biotech drugs and small-molecule therapies alike.
Among the potential blockbusters approved by the FDA last year: Eli Lilly's and Daiichi Sankyo's blood thinner Effient and Sanofi-Aventis' Multaq. Amgen's D-mab and Liraglutide from Novo Nordisk, meanwhile, are still on hold long after approvals were expected.