Portola Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has extended the review period for the company’s marketing authorization application, or MAA, for Ondexxya and cancelled the oral explanation scheduled for December 12. An opinion is now expected by February 28, 2019. The CHMP informed Portola that it will provide a list of outstanding questions related to the data package the company submitted for Ondexxya last quarter, which will require additional responses from the company. The preliminary timetable provided to the company by the CHMP sets a deadline of January 29, 2019 for responses to the questions followed by a 30-day assessment period for the CHMP to review the company’s responses. Ondexxya is under review for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
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