CHMP backs smallpox vaccine, lipegfilgrastim, CSL bleeding product

EMA's CHMP issued a positive opinion recommending approval of an MAA from Bavarian Nordic A/S (CSE:BAVA) for its Imvanex smallpox vaccine. Bavarian has been supplying the third-generation modified vaccinia Ankara (MVA) virus vaccine to the U.S. Strategic National Stockpile since 2010. The vaccine is in Phase III testing in the U.S.

CHMP also backed approval of Lonquex lipegfilgrastim from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to prevent chemotherapy-induced neutropenia. Teva gained the glyco-pegylated recombinant human granulocyte colony-stimulating factor (G-CSF; CSF3) through its 2010 acquisition of ratiopharm GmbH. The committee also recommended approval of Voncento from CSL Ltd. (ASX:CSL) to treat and prevent bleeding in patients with hemophilia A and von Willebrand disease (vWD). The lyophilized concentrate of antihemophilic factor and von Willebrand factor (vWF) complex is approved as Humate-P in the U.S. ...