FDA accepts Takeda’s alogliptin NDA, says PPD
PPD partnered with Takeda to develop the compound. Under PPD’s agreement with Takeda, the FDA’s acceptance of the NDA filing triggers a $15 million milestone payment to PPD.
Amgen has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Repatha (evolocumab) supporting its broader use prior to a first heart attack or stroke.