Pfizer, Novartis win EU nods for new leukemia, eye drugs
Pfizer and Novartis emerged as winners this week in a review of drug applications in the European Union, with delegates backing approval of the drug giants' new meds. With both drugs, the FDA beat its European counterpart to the punch with approvals last year.
Nevertheless, the support from the European Medicines Agency's CHMP is welcome news for the pharma outfits, as the European Commission typically stamps approvals based on such recommendations within months.
Novartis ($NVS) won a positive opinion from the CHMP for Jetrea, a pioneering therapy for vitreomacular traction, a condition that causes separation of the jelly-like substance in the eye and leads to vision loss and blindness. Jetrea, which the pharma licensed from ThromboGenics in a €375 million deal last year, provides a novel alternative to surgery for VMT patients.
This week ThromboGenics debuted Jetrea in the U.S., where the FDA stamped an approval on the drug in October and it could become a $500 million seller, Bloomberg reported. Its FDA approval was part of a productive 2012 that saw 39 new drug nods from the agency, which prided itself on being the first to approve new meds in the majority cases last year.
Pfizer ($PFE) was also on the winning side of the FDA's bust-out year for drug approvals. Today the CHMP backed conditional approval of the company's kinase inhibitor bosutinib, which U.S. regulators green-lighted back in September. European regulators supported the use of the drug for patients with Philadelphia chromosome positive chronic myelogenous leukemia who have failed treatment with other kinase inhibitors.