The latest set of opinions from the European Medicines Agency includes recommendations for Roche's breast cancer drug Perjeta and Lundbeck/Biotie's anti-alcohol pill Selincro.
First up, the agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Perjeta (pertuzumab) in combination with Roche's blockbuster Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable breast cancer (mBC). The recommendation supports an indication for people with this specific type of cancer who have not received prior anti-HER2 therapy or chemotherapy.
The drug was approved by the US Food and Drug Administration and Hal Barron, Roche’s chief medical officer, said "we believe Perjeta will transform the way people with HER2-positive mBC are treated".
The CHMP has also recommended marketing authorisation of Selincro (nalmefene), which Lundbeck R&D chief Anders Gersel Pedersen said "represents the first major innovation in the treatment of alcohol dependence in many years". Once approved, the Danish firm says it will provide Selincro, an opioid system modulator, as part of "a new treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence".
Noting that "this is a historic occasion for Biotie", the Finnish drugmaker's chief executive Timo Veromaa said Selincro will be the first product "specifically developed to reduce alcohol consumption without the need to completely abstain from drinking. In Europe alone, over 10% of all deaths in adults are attributable to alcohol - this represents a huge medical burden".
There was also a thumbs-up for Alexza Pharmaceuticals' Adasuve (loxapine) for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The CHMP has recommended that the treatment should be administered only in hospital under the supervision of a healthcare professional.
Other highlights from the CHMP's meeting includes backing for label extensions for Otsuka's schizophrenia drug Abilify (aripiprazole), Novartis' Ilaris (canakinumab) for the treatment of cryopyrin-associated periodic syndromes (CAPS) and Intercell's Japanese encephalitis vaccine Ixiaro.