Last year's awful record of new drug approvals by the FDA has been followed by a burst of new activity. Pharmalot reports new analysis indicating 29 new drug approvals through April, the fastest rate of acceptance since 1998 and 2000. And that's way up from the anemic 16 approvals posted for the same period last year. But ten of the 29 approvals are for therapies that build on existing drugs and there were only three NME approvals for the period.
"We view NME approval trends as a more critical metric than overall new drug approval trends because NMEs represent novel compounds carving out entirely new pharmaceutical niches. These are the compounds that break new clinical ground and require the most effort in educating physicians, patients, and payers," writes Jim Kumpel, a healthcare analyst at Friedman Billings Ramsey.
- read the report in Pharmalot