CHMP backs Fluenz, Sprycel, Lucentis, Sutent
The European Medicines Agency's CHMP issued several positive opinions on Friday, including recommending approval of Fluenz intranasal live attenuated influenza vaccine (LAIV) from MedImmune LLC to prevent seasonal influenza in children from 24 months to less than 18 years of age. MedImmune is a subsidiary of AstraZeneca plc (LSE:AZN; NYSE:AZN).
The EMA committee also backed expanded labels for three drugs, including Sprycel dasatinib from Bristol-Myers Squibb Co. (NYSE:BMY) for first-line treatment of newly diagnosed adult patients with chronic myelogenous leukemia in chronic phase (CML- CP). Sprycel is already approved for CML and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients who are resistant to or intolerant of prior therapy. ...