As Vivus ($VVUS) sank on bad news about its weight drug in Europe, Pfizer ($PFE), Bristol-Myers Squibb ($BMY) and a pack of other pharma groups won endorsements for their new therapies from the European Union's drug regulator. The European Commission will have the final say on the companies' drug apps.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) backed approval of Pfizer and Bristol's Eliquis (apixaban) for a new use, supporting a green light for the anti-clotting agent to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) and at least one other risk factor for stroke. The drug giants have pinned much of their blockbuster hopes for apixaban on the large AF market, yet earlier this summer the FDA handed the partners a setback with the agency's delay on deciding whether to grant an approval on the drug. The anti-clotting drug was approved in Europe last year for a more limited market than AF.
The following are some of the CHMP's other positive opinions:
As Reuters reported, the EU regulator gave its stamp to Regeneron ($REGN) and Bayer's Eylea for treating patients with wet age-related macular degeneration, a major cause of blindness in elders. The news service noted that the drug offers a cheaper alternative to Roche's ($RHHBY) Lucentis with the bonus of fewer injections into the eye.
The group backed approval of Novartis' ($NVS) Votubia (everolimus) for adults with non-cancerous renal angiomyolipoma associated with tuberous sclerosis complex (TSC), based on a variety of risk factors, according to the company.
Boehringer Ingelheim (BI) and Eli Lilly ($LLY) said that the CHMP recommended approval of an expanded use of the two companies' Type II diabetes drug Trajenta (linagliptin). The new approval would allow use of the drug with insulin and with or without metformin in certain cases in order to help patients gain glycemic control.
- here's Pfizer's release
- see Novartis' release
- get BI's statement
- and Reuters' report