CHMP backs swine flu vaccines, Multaq, Prevenar 13 and more

The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use are dominated by support for GlaxoSmithKline and Novartis’ swine flu vaccines but also include good news for Sanofi-Aventis, Wyeth and Zeltia, among others.

First up, two vaccines against influenza A (H1N1) have been recommended for authorisation in Europe, Novartis’ Focetria and Pandemrix from GlaxoSmithKline. The CHMP also gave its backing to the Swiss company’s Onbrez Breezhaler (indacaterol) for the maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

The EMEA also adopted positive opinions on Sanofi’s Multaq (dronedarone) to prevent recurrence of atrial fibrillation and Wyeth’s Prevenar 13 for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae. It also backed Biotest Pharma’s Zutectra for the prevention of hepatitis B virus re-infection in HBV-DNA negative patients after liver transplantation.

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The Committee also issued positive opinions for a wide range of generics. Teva and Actavis have moved closer to getting approval for their versions of Pfizer’s erectile dysfunction Viagra (sildenafil), while the Israeli firm has also been given recommendations for its copies of Sanofi’s antihypertensive CoAprovel (irbesartan) and two HIV drugs – GSK’s Epivir (lamivudine) and Boehringer Ingelheim’s Viramune (nevirapine). India’s Glenmark has received a positive opinion for its generic version of Eli Lilly’s Zyprexa (olanzapine),

The CHMP also gave its backing to an extension for Roche’s Tamiflu (oseltamivir), to include treatment of children less than six months of age during pandemic influenza and post-exposure prophylaxis for those younger than one. It also gave positive opinions for Merck Sharp and Dohme’s diabetes drugs Janumet (sitagliptin/metformin) and Januvia (sitagliptin) to include combination therapy with insulin,

The Committee also looked favorably on Zeltia’s soft-tissue sarcoma drug Yondelis (trabectedin) to be used in combination with Johnson & Johnson’s Doxil (doxorubicin) for the treatment of relapsed ovarian cancer.