MDCO's Angiomax sNDA not approvable

The Medicines Company (MDCO) received a not-approvable letter from FDA for its sNDA to expand the label of Angiomax bivalirudin to include patients undergoing percutaneous coronary intervention (PCI) with heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS). The agency's letter requested data from additional studies and cited "deficiencies in the study methods used and in the analysis of the clinical data." MDCO said it plans to request a meeting with FDA. ...