Europe’s drugs regulator gave its backing for marketing approval to be granted for Bayer’s pulmonary hypertension drug Adempas and for GlaxoSmithKline’s diabetes medicine Eperzan.
The European Medicine Agency also backed a new drug from Dainippon Sumitomo Pharma called Latuda, for the treatment of schizophrenia, and Bemfola, a new biosimilar medicine for the treatment of infertility.
But the regulator decided against recommending Teva’s new multiple sclerosis (MS) pill Nerventra, or laquinimod, which the Israeli firm is developing with Swedish partner Active Biotech, and recommended rejecting an application from Swiss drugmaker Novartis to market its heartfailure drug serelaxin.
Recommendations for marketing approval by the EMA’s Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within a couple of months.
The prospects for laquinimod were already viewed by analysts as uncertain, since the drug missed its main goal in a late-stage trial in 2011 and US regulators have asked for another Phase III study before considering it.
Analysts at Jefferies in London said the rejection of Teva’s MS drug was as they had expected and was driven by three major concerns – about the possible link to risk of cancers and pregnancy dangers, and its modest effect on relapse rates which suggested an unfavourable risk-benefit balance for the drug.
On Bayer’s Adempas, the EMA said the key benefits of the drug were “its ability to providesignificant improvement in exercise capacity and pulmonary haemodynamics in two specific conditions known as chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension.”
Adempas, which belongs to a class of drugs known as soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure, got backing from drugs regulators in US in October last year, and in Japan earlier this month.
The EMA also issued negative opinions for two so-called orphan medicines – Masiviera from France’s AB Science, intended for certain types of advanced pancreatic cancer, and Translarna, from PTC Therapeutics, designed to treat Duchenne muscular dystrophy.
GSK’s once-weekly diabetes drug albiglutide won the EMA’s recommendation and will be sold under the brand name Eperzan. It belongs to the same class of injectable GLP-1 drugs as Victoza, from Novo Nordisk, as well as Byetta and Bydureon, from Bristol-Myers Squibb and AstraZeneca.