Amgen and GlaxoSmithKline head the list of beneficiaries from the latest set of opinions issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

First up, the CHMP has recommended approval of Amgen’s Prolia (denosumab), for the treatment of osteoporosis in postmenopausal women at increased risk of fractures and for bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. If given the full green light, denosumab will be co-marketed by GSK.

The latter got some good news of its own as well as the Committee recommended approval of Revolade (eltrombopag) for chronic idiopathic thrombocytopenic purpura. The drug is already sold in the USA as Promacta iand is the result of a collaboration between GSK and Ligand Pharmaceuticals.

The CHMP also adopted a positive opinion for Sanofi-Aventis/Bristool-Myers Squibb’s DuoPlavin, a fixed combination of Plavix (clopidogrel) and acetylsalicylic acid for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both treatments. There were also recommendations for Cangene’s hepatitis B vaccine ImmunoGam and Novartis’ meningitis jab Menveo.

Negative on Ark’s Cerepro
However, the CHMP had some bad news for Ark Therapeutics, adopting a negative opinion on (sitimagene ceradenovec), the UK firm’s gene-based therapy for brain cancer. The Committee said that the benefits of Cerepro did not outweigh its risks, a decision which led to Ark’s shares sinking over 43% to 17 pence.

Positive opinions were also adopted for Novartis and Hospira’s generic versions of Schering-Plough's Temodal (temozolomide) for glioblastoma and extensions of indication for Roche’s Herceptin (trastuzumab) and B-MS’ Orencia (abatacept). The CHMP has also concluded a review of benfluorex, which is used as an add-on treatment in patients with diabetes who are overweight, and said the benefits of the treatment no longer outweigh its risks, and that all marketing authorisations for medicines containing benfluorex should be revoked.