The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use include good news for Johnson & Johnson and UCB’s rheumatoid arthritis drugs Simponi and Cimzia, and recommendations for broader use Novartis’ Aclasta and Xolair.
First up and J&J’s Simponi (golimumab), which is partnered, for now, with Schering-Plough, has been recommended for approval to treat moderate to severe rheumatoid arthritis, as well as psoriatic arthritis and ankylosing spondylitis. Cimzia (certolizumab pegol) has also been backed by the CHMP for RA.
The CHMP has also issued a positive opinion on Pierre Fabre’s Javlor (vinflunine ) as a monotherapy in the metastatic treatment of bladder cancer after a failure of a prior platinum-containing regimen. AstraZeneca and Bristol-Myers Squibb got a positive opinion on Onglyza (saxagliptin) for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.
The regulators has also have broadened approval for Novartis’ bone drug Aclasta (zoledronic acid) to treat osteoporosis caused by steriod treatment in men and postmenopausal women. The CHMP also says that the Swiss major should be allowed to market Xolair (omalizumab) to patients aged 6 to 12. The drug is already approved for adults and adolescents.
Other positive opinions that were granted included one for Roche’s Avastin (bevacizumab) to be combined with docetaxel for the first-line treatment of advanced breast cancer. Merck & Co’s diabetes drug Januvia (sitagliptin) was recommended as monotherapy in patients for whom metformin is inappropriate, while a once-daily formulation of Boehringer Ingelhein's Mirapexin/Sifrol (pramipexole) for Parkinson's Disease also received a positive opinion.
The CHMP also recommended approval of Krka’s Vizarsin, a generic of Pfizer’s erectile dysfunction drug Viagra (sildenafil) and backed a fresh raft of generic versions of Sanofi-Aventis/Bristol-Myers Squibb’s Plavix (clopidogrel). In addition, the EMEA announced that it was recommending the gradual withdrawal of dextropropoxyphene-containing drugs as the risks associated with the painkillers outweigh their benefits.