Swiss pharma giant Novartis ($NVS) has earned an endorsement from the European Committee for Medicinal Products for Human Use (CHMP) for its once-daily Ultibro Breezhaler to treat chronic obstructive pulmonary disease. The nod was one of 8 new CHMP-recommended medicines for approval this week.
Novartis' Xoterna Breezhaler--known as QVA149 in clinical trials--received a positive opinion from the committee for COPD, a group of lung diseases that includes emphysema, chronic bronchitis, and, in some cases, asthma. According to the Centers for Disease Control and Prevention (CDC), COPD was the third-leading cause of death in the U.S. in 2011.
Ultibro Breezhaler is a fixed-dose combination of Indacaterol, a beta-2-adrenergic agonist, and Glycopyrronium Bromide, an anticholinergic. Indacaterol works by causing the muscles of the airways to relax, while glycopyrronium helps to dilate the airways. In clinical trials, the inhaler improved lung function and reduced flare-ups. A U.S. filing is expected at the end of 2014. The CHMP also gave a positive recommendation for Novartis' Xoterna Breezhaler.
Following an FDA approval earlier this month for Boehringer Ingelheim's Giotrif (afatinib), the targeted therapy for non-small cell lung cancer also scooped up a recommendation by CHMP this week.
The CHMP also recommended marketing authorizations for Takeda Pharmaceuticals' Incresync, Vipdomet and Vipidia for the treatment of Type 2 diabetes, Gilead Sciences' ($GILD) Tybost for HIV, and Apotex Europe's Grastofil for neutropenia, a condition of an abnormally low number of white blood cells.
Japaense drugmaker Otsuka's treatment delamanid for multi-drug resistant tuberculosis received a negative opinion from the committee, which expressed concern that the duration of treatment in the main study was too short to determine the effectiveness of the therapy.
The European Commission typically endorses CHMP's recommendations for marketing approval within a couple of months.
- here's the CHMP bulletin
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