RGEN - Biotech News Recap: Portola Gains Approval In Europe For Ondexxya
Portola Pharmaceuticals (PTLA) - The company announced that the European Commission granted conditional Marketing Authorization for Ondexxya (andexanet alfa) to be used in adult patients treated with the Factor Xa inhibitor apixaban or rivaroxaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. As one can imagine, given that there were previously no approved treatment options for these patients, this comes as welcome news. Data from dual phase 3 studies (ANNEXA-R and ANNEXA-A) was quite convincing (along with results from phase 3b/d ANNEXA-4 trial) and has been published. Management should