The latest set of opinions from the European Medicines Agency has brought good news for Roche and Daiichi Sankyo's personalised cancer drug Zelboraf.
The agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Zelboraf (vemurafenib) for melanoma patients whose tumours express a gene mutation called BRAF V600E. Roche noted that the drug was approved in the USA in August, as was a companion diagnostic co-developed by Roche to detect the BRAF V600E mutation.. The test is also commercially available in the European Union.
The CHMP has also issued a positive opinion on Gedeon Richter's Esmya (ulipristal) for the treatment of pre-operative treatment of moderate to severe symptoms of uterine fibroids. The Hungarian firm got access to the product through its 2010 acquisition of Switzerland's PregLem.
The agency also backed Vepacel, Baxter's A/H5N1 pre-pandemic influenza vaccine and recommended extending the label on Novartis' diabetes drug Galvus (vildagliptin) and Servier’s angina drug Procoralan (ivabradine). It also recommended approval of a 10-mg/ml syrup of UCB's anti-epilepsy medicine Vimpat (lacosamide) to replace the 15-mg/ml syrup recalled earlier this year.
Positive on somatropin treatments
Finally, the EMA said that after a comprehensive review, it has ruled that the benefits of the human growth hormone somatropin outweigh the risks. The investigation began following data indicating a potentially higher risk of death in patients who took the treatment.
Currently there are three somatropin-containing medicines centrally authorised in the European Union – Sandoz’ Omnitrope (the first biosimilar to be approved in Europe), BioPartner’s Valtropin and Ipsen’s NutropinAq – but several others, including products marketed by Pfizer (Genotropin) and Eli Lilly (Humatrope), have also been authorised via national channels throughout the region.