CHMP backs Teva's Egranli for neutropenia

EMA's CHMP recommended marketing authorization of Egranli balugrastim from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to prevent chemotherapy-induced neutropenia. Approval will include a pharmacovigilance plan.

Last November, Teva withdrew a BLA for the long-acting recombinant human G-CSF fused to human albumin, which had been under FDA review for neutropenia. The company could not be reached for comment on the current status of Egranli in the U.S. ...