The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use have brought good news for Eli Lilly, Boehringer Ingelheim and Roche.
First up, the CHMP has recommended approval of Eli Lily's Bydureon (extended-release exenatide), developed with Amylin and Alkermes for type-2 diabetes. The drug is a long-acting once-weekly version of Byetta and the European recommendation is a boost for the firms who saw Bydureon rejected by the US Food and Drug Administration last year.
Also granted a positive opinion was Nulojix (belatacept), from Bristol-Myers Squibb, intended in combination with corticosteroids and a mycophenolic acid for graft rejection in adults receiving a kidney transplant. The regulator has also backed Leganto (rotigotine), UCB's copy of its own patch Neupro.
In terms of positive opinions for extensions of indications, the most eye-catching is the CHMP's support for Boehringer Ingelheim's Pradaxa (dagibatran) to include the prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation. It is already approved in Europe to prevent clots after hip and knee surgery, but this recommendation, the first new drug in this area for 50 years, will push Pradaxa towards blockbuster status.
Other extensions were recommended for Recordati's Carbaglu (carglumic acid) to include the treatment of hyperammoniaemia due to acidaemia, Allergan's eye drug Ozurdex (dexamethasone) and Johnson & Johnson's Simponi (golimumab) to include the reduction of the rate of progression of peripheral joint damage in patients with polyarticular symmetrical subtypes of psoriatic arthritis.
U-turn on Avastin/Xeloda for breast cancer
The EMA also announced that following a re-examination of its previous negative opinion, it has recommended that the licence on Roche's Avastin (bevacizumab) should be extended to include first-line treatment in combination with the Swiss firm's Xeloda (capecitabine) of patients with metastatic breast cancer in whom treatment with other chemotherapies, is not considered appropriate. At the end of last year, it said Avastin should only be used to treat advanced breast cancer in combination with paclitaxel, not with Xeloda or docetaxel.
Meantime, the CHMP has recommended that the label for GlaxoSmithKline's flu vaccine Pandemrix should be amended to advise prescribers to take into account preliminary results from studies linking its use to narcolepsy in children and teenagers, and to perform an individual benefit-risk assessment. This is an interim measure pending the outcome of the European review expected to conclude in July 2011, the EMA stressed, as the relationship between Pandemrix and narcolepsy is still under investigation.
The committee also confirmed that the benefits of bisphosphonates in the treatment and prevention of bone disorders "continue to outweigh their risks", but that a warning of the risk of atypical femoral fractures should be added to the label for all bisphosphonate-containing medicines.