Sharp dip in US drug approvals forecast
The US Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 than it did last year, as the industry faces a number of ongoing operational risks, according to a new report.
The total of 30 new primary care and specialty medicines approved for marketing in the US in 2011 will be hard to beat this year, warns the study, from Fitch Ratings. Despite a strong first quarter, with eight New Molecular Entities (NMEs) approved, the total of 14 new approvals in first-half 2012 lags behind the 18 new approvals in the same period of 2011.
While the research success of branded drugmakers in 2011 will be difficult to repeat, their more modest goal of filing 12 new medicines for marketing authorisation this year is "obtainable," says the ratings agency. "Last year, branded drug manufacturers reached three-fourths of their target for regulatory registration, submitting 18 of 24 over therapies for review with drug authorities," the report notes.