Posted by Michael Wonder on 12 Dec 2018
CHMP extends review period for Portola Pharmaceuticals’ Ondexxya (andexanet alfa)
11 December 2018 - Portola Pharmaceuticals today announced that the CHMP of the EMA has extended the review period for the Company’s marketing authorisation application for Ondexxya (andexanet alfa), and cancelled the oral explanation scheduled for Wednesday, 12 December 2018.
An opinion is now expected by 28 February 2019.
The CHMP informed Portola yesterday 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 29 January 2019 for responses to the questions followed by a 30 day assessment period for the CHMP to review the Company’s responses.
