April 6 Quick Takes: Makena pulled from market
Plus: Takeda ending early AAV gene therapy, rare hematology work and updates from Pharmakon, Capacity Bio
More than 12 years after it received accelerated approval to prevent preterm births in high-risk pregnancies, and three and a half years after the agency proposed its withdrawal, FDA Thursday announced the withdrawal of Makena from Covis Pharma S.a.r.l., as well as generic versions of the drug. The withdrawal process, prolonged by the company’s requests for an advisory committee meeting and other procedural steps, has served as a poster child for FDA’s requests to Congress for greater power to pull drugs off the market.
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) is discontinuing its discovery and preclinical activities in AAV gene therapy, and research and preclinical initiatives in rare hematology, to focus its resources on its core therapeutic areas and late-stage clinical programs, according to a company spokesperson. The company’s clinical development pipeline and commercial products will not be affected by the move. ...