The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use includes a recommendation for Merck & Co’s fertility treatment Elonva and a rejection of Roche’s Avastin for glioblastoma.
The CHMP has adopted a positive opinion for Elonva (corifollitropin alfa), which Merck got hold of through its recent acquisition of Schering-Plough. It is indicated for controlled ovarian stimulation for the development of multiple follicles in women participating in an assisted reproductive technology programme. Mirjam Mol-Arts, senior vice president of Merck Research Laboratories, said that if approved, Elonva will reduce the burden of injections for women experiencing difficulty conceiving.
The committee has also backed Recordati’s Urorec/Silodyx (silodosin) for benign prostatic hyperplasia and Teva’s generic versions of three drugs – Sanofi-Aventis’ Taxotere (docetaxel) for a variety of cancers, Boehringer Ingelheim’s antihypertensive Micardis (telmisartan) and Schering-Plough’s Temodal (temozolomide) for glioblastoma.
There was worse news for Antigenics as the CHMP adopted a negative opinion on Oncophage (vitespen), the US firm’s vaccine for kidney cancer. However, the firm, which has now withdrawn its filing, said it hopes to supply Oncophage, “as requested, under a named patient programme in Europe, in addition to its ongoing commercial efforts in Russia” and named patient programs elsewhere globally.
The committee also recommended not granting marketing authorisation to Axxonis Pharma’s Nenad (lisuride) for the treatment of restless legs syndrome.
Roche disappointed
The CHMP has also decided not to back Roche’s oncology blockbuster Avastin (bevacizumab) either alone or in combination with irinotecan in patients with glioblastoma after relapse. It is concerned that the Swiss company had not provided sufficient evidence of the medicine’s benefits, “because the number of patients who responded to treatment was not dramatic and because response rates may not be a suitable measure of the medicine’s effectiveness”. The CHMP added that it could not interpret the findings on survival because the study did not compare Avastin directly with any other treatments.
William Burns, chief executive of Roche’s pharmaceuticals division, said “we are very disappointed with the CHMP opinion which will result in a delay to patients receiving an important new treatment option”. He added that “we strongly believe that Avastin is a new treatment option for physicians within the EU which would bring hope to GBM patients and their families as it is today in the USA and other countries”.
The EMEA also noted said that single doses of GlaxoSmithKline’s Pandemrix and Novartis’ Focetria influenza A (H1N1) vaccines would provide sufficient protection against the virus for the majority of people, after previously recommending two doses. Data on Baxter’s Celvapan is still under review.
