FDA Drops Restricted Access Requirement For Amgen’s Nplate And GSK’s Promacta
This article was originally published in The Pink Sheet Daily
FDA’s decision to modify the risk program for thrombocytopenia treatments may influence CMS to drop Nplate from its list of potential National Coverage Determinations.
You may also be interested in...
Supplemental approval for severe aplastic anemia, a “breakthrough” designation, was based on a single-center, open-label Phase II trial in 43 patients that was conducted by the National Heart, Lung and Blood Institute.
A look at the safety record of a drug in foreign countries where REMS elements are not in play could differentiate the impact of a REMS compared to other risk management efforts, Amgen suggests.
More than half of a 26-member advisory committee supports eliminating or easing the REMS for GSK’s diabetes drug, but the spilt vote and high-profile of the product’s safety issues suggest that FDA is unlikely to modify Avandia’s risk management.