Portola Pharmaceuticals Inc. said the European Medicines Agency's Committee for Medicinal Products for Human Use requested additional information for its drug betrixaban, which is under review for approval.
Portola's head of research and development, John Curnutte, said the agency's questions can be addressed with existing clinical data. The company has until Jan. 23, 2018, to respond to the questions.
Based on this new timeline, the company expects the EMA's committee to issue an opinion on the drug sometime later in the first quarter of 2018.
Betrixaban is already approved by the U.S. Food and Drug Administration under the brand name Bevyxxa as a blood thinner to prevent and treat clots in patients.
