Advisors to the European Medicines Agency have recommended the approval of eleven new medicines in the region, including a new treatment for skin cancer and the first therapy for the rare condition non-24-hour sleep-wake disorder.
First up, the Committee for Medicinal Products for Human Use has endorsed marketing authorisation for Bristol-Myers Squibb’s Opdivo (nivolumab), for the treatment of adults with advanced (unresectable or metastatic) melanoma.
The immunotherapy is the first cancer treatment selectively targeting PD-1 put forward for approval in the EU, its backing based on clinical trial data showing strong response rates and survival benefits.
The Committee also recommended marketing authorisation for Vanda Pharmaceuticals’ Hetlioz (tasimelteon) to treat non-24-hour sleep-wake disorder in totally blind adults, for which there is currently no available treatment in the EU.
The drug, which picked up orphan designation in 2011, attaches to the receptors that melatonin normally attaches to co-ordinate the body’s sleep cycle, thus promoting sleep and regulating sleep patterns.
Daiichi Sankyo’s Lixiana (edoxaban) received a positive CHMP opinion for the prevention of stroke and systemic embolism in atrial fibrillation, and the prevention and treatment of venous thromboembolism, while I.D.B. Radiopharmacy’s LuMark (Lutetium (177Lu) chloride) was backed for the radio-labelling of carrier molecules.
Elsewhere, Generic medicines finding favour with the CHMP were: Pharmathen’s Aripiprazole Pharmathen and Zentiva’s Aripiprazole Zentiva for schizophrenia and treatment and prevention of manic episodes of bipolar 1 disorder; Generics UK’s Duloxetine Mylan for major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder; Generics UK’s Pregabalin Mylan for epilepsy and generalised anxiety disorder; Generics UK’s Pregabalin Mylan Pharma for neuropathic pain, epilepsy and generalised anxiety disorder; Sandoz’ Pregabalin Sandoz for epilepsy, neuropathic pain and generalised anxiety disorder; and Pregabalin Sandoz GmbH for epilepsy and generalised anxiety disorder.
On the downside, Biovest Europe’s Lympreva (dasiprotimut-T), intended for the treatment of patients with follicular non-Hodgkin’s lymphoma, was turned down. The Committee said the way the main study was designed and carried out was inadequate to establish the medicine’s benefit, and there were also concerns over aspects of manufacturing and quality control.