The latest set of opinions from advisors to the European Medicines Agency sees five new medicines and two generics recommended for approval.
First up, the agency’s Committee for Human Medicinal Products (CHMP) has issued a positive recommendation on Astellas and Medivation’s Xtandi (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. It was approved by the US Food and Drug Administration in August last year.
The CHMP also backed Roche’s Erivedge (vismodegib), for the treatment of advanced basal cell carcinoma. However, the recommendation is conditional, a status granted to a drug when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. Roche must provide comprehensive clinical data at a later stage on the treatment, which was co-developed with Curis.
The committee has also recommended that Vivus’ Spedra (avanafil) should be granted marketing authorisation for the treatment of erectile dysfunction. The announcement came a year after the FDA approved the drug.
The agency’s advisors have also backed approval of the “first combined tissue-engineered medicine to be authorised across the European Union”, namely MACI (matrix-induced autologous chondrocyte implantation). The latter is an advanced-therapy medicinal product (ATMP) developed by Sanofi unit Genzyme for the repair of cartilage defects.
The committee also gave a positive recommendation for Avanir Pharmaceuticals’ Nuedexta (dextromethorphan/quinidine), the first treatment for pseudobulbar effect (PBA) approved in Europe. PBA is a neurologic condition in which patients experience sudden and uncontrollable bouts of laughing or crying; it occurs when disorders such as multiple sclerosis and amyotrophic lateral sclerosis or a stroke, damage areas of the brain involved in the control of normal expression of emotion.
The CHMP also recommended approval for expanded use of Celgene’s Revlimid (lenalidomide) as a treatment for anaemia in patients with myelodysplastic syndromes and Roche’s rheumatoid arthritis treatment RoActemra (tocilizumab), specifically for the treatment of polyarticular juvenile idiopathic arthritis. Positive opinions were also granted for Accord Healthcare’s generic version of Novartis’ leukaemia drug Glivec (imatinib) and Sun Pharma’s copy of Roche’s chemotherapy Xeloda (capecitabine).
