EMA approves 5 new drugs in Europe

April 29, 2013 | By Márcio Barra

EMA’s CHMP 22-25 April 2013 meeting occurred last week, with 5 new drugs attaining marketing authorization (MA) and 2 new generics MAs approved. Here is the rundown of approvals and refusals:

Approved marketing authorizations for new drugs

Erivedge (vismodegib), Roche Registration Ltd –An oral, small-molecule antineoplastic agent that acts by blocking specific genes involved in proliferation, survival, and differentiation of cells.It is intended for the treatment of adult patients with symptomatic metastatic basal cell carcinoma. The recommendation is conditional, as further data is still needed. A pregnancy prevention plan will be implemented alongside the pharmacovigilance plan, as Erivedge can cause embryo-fetal death or severe birth defects.

MACI (matrix applied characterised autologous cultured chondrocytes), Genzyme Europe B.V. – An implantable matrix consisting of characterized autologous cultured chondrocytes on a collagen membrane, intended for implant into cartilage defects of damaged knees. It is an advanced therapy medicinal product (ATMP), and the first combined tissue-engineered medicine to be authorized in the European Union.

Nuedexta (dextromethorphan hydrobromide, quinidine sulfate), Jenson Pharmaceutical Services Ltd – The first treatment for pseudobulbar affect approved in Europe, a medical condition where patients experience sudden and uncontrollable bouts of laughing or crying, due to brain damage on areas of the brain involved in the control of normal expression of emotion.

Dextrometorphan acts on the glutamate neurotransmitting pathways that regulate emotional expression, while quinidine inhibits dextrometorphan’s metabolism, thus increasing its blood concentration.

Spedra (avanafil), VIVUS B.V. – A tablet intended for the treatment of erectile dysfunction in adult men. Avanafil is a selective phosphodiesterase (PDE) type 5 inhibitor that leads to higher cyclic guanosine monophosphate (cGMP)-specific PDE5 levels. This enhances smooth muscle relaxation, which results in an inflow of blood into the penile tissues and erection.  This approval comes a year after the FDA approved the drug.

Xtandi (enzalutamide), Astellas Pharma Europe B.V. – For the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. Enzalutamide is a potent androgen receptor signaling inhibitor that blocks several steps in the androgen receptor signaling pathway. It was approved by the US Food and Drug Administration in August last year.

Also, Xeljanz (tofacitinib citrate), from Pfizer, was not approved treatment of rheumatoid arthritis by the CHMP, on the basis of insufficient efficacy – “(studies) were not sufficient to show a consistent reduction in disease activity and structural damage to joints” – and overall safety concerns. Xeljanz was approved in November 2012 by the FDA.



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