A slew of regulatory news out of Europe today as the European Medicines Agency weighs in on a laundry list of new drugs and new indications for old ones. Here's a roundup, with new indications first.
- The Novartis med Aclasta got the nod for broader use. Known as Reclast in the U.S., the bone drug was up for approval as a treatment for steroid-induced osteoporosis in men and postmenopausal women. Article
- Roche's Avastin could see broader use as the regulators gave a positive opinion to the drug as part of a combination treatment for patients with advanced breast cancer. Report
- Merck's diabetes drug Januvia got the nod as a first-line treatment; previously it had been approved for use in combination with metformin or a sulfa drug. Report
- Novartis got the thumbs up for broader use of its asthma drug Xolair; the indication would be extended to pediatric patients from 6 to 12 years. It's already approved for adults and adolescents. Release
- Johnson & Johnson and Schering-Plough's once-monthly drug Simponi has been recommended for approval to treat moderate to severe rheumatoid arthritis. The injectable drug also got a positive opinion as a treatment for psoriatic arthritis and ankylosing spondylitis. Simponi is a follow-up to the drugmakers' blockbuster drug Remicade. Story
- UCB got the thumbs up for its rheumatoid arthritis treatment Cimzia, which is already available in the U.S. The Belgian company collaborates on the drug with U.S.-based Nektar Therapeutics, which would get royalties on sales if Cimzia gets final EU approval, which is expected within a few months. Report
- AstraZeneca and Bristol-Myers Squibb got a positive opinion on Onglyza (saxaglptin) as an add-on treatment for type 2 diabetes in adults. Report
- Meanwhile, Roche filed its MabThera cancer drug for European approval as a first line biologic treatment for rheumatoid arthritis. The new filings are for patients who have not been treated with methotrexate (the current standard treatment option), for those who have had an inadequate response to methotrexate, and to prevent joint damage in all RA patients. News
All these positive recommendations have to be ratified at the European Commission level, so stay tuned.
- get the CHMP overall press announcement (pdf)