CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions Friday, including Ondexxya andexanet alfa and Waylivra volanesorsen.

The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first approved antidote for adult patients taking the anticoagulant drugs Eliquis apixaban or Xarelto rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding. FDA has approved the product as Andexxa. The drug is a modified human Factor Xa protein that acts as a decoy to target and sequester Factor Xa inhibitors (see "Portola Jumps on FDA Approval of Andexxa")...