FDA’s racking up drug approvals lickety-split
By mid-2017, the FDA approved a record number of drugs that have sales firepower and one very high price.
Friday’s approval for anticoagulant Bevyxxa has already become 23 in this year, exceeding the number of approvals for the entire 2016, which, according to agency statistics, was 22. Other recent approvals include such drugs as Baxdela and Kevzara, produced by Melinta Therapeutics, Sanofi and Regeneron, respectively. The first serious reason for this outcome was that U.S. drug regulator signed off more drugs (12) in the first three months of the year than during any other first quarter in recent years.
Interestingly, one of the new drugs this year caused price controversy and two drugs have serious sales firepower. And among those 23, one has joined the ranks of the world’s most expensive treatments.
The FDA’s new drug approval tally for 2016 came in as a major slowdown from boom years of 2014 and 2015, when the agency approved 41 and 45 new meds, respectively.
Source: fiercepharma.