Green light for new medicines

by Gary Finnegan: The European Medicines Agency (EMA) has recommended 10 new medicines for approval, taking the total approvals for 2014 to 75 with one additional meeting still to come before the end of the year.

At its meeting in late November, the influential Committee for Medicinal Products for Human Use (CHMP) approved two new products for the treatment of chronic hepatitis C.

Exviera (dasabuvir) and Viekirax (ombitasvir + paritaprevir + ritonavir) – both from AbbVie – were reviewed under ‘accelerated assessment’. They belong to a new generation of antiviral products for chronic hepatitis C infection that have high cure rates and have recently reshaped the treatment landscape for the disease.

While hepatitis C grabbed the headlines, the other big story from the CHMP was the approval of two new orphan medicines: Cerdelga (eliglustat), for the treatment of Gaucher disease type 1, and Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis.

Other highlights included:

–          Cosentyx (secukinumab) and Otezla (apremilast), new treatment options for psoriasis.

–          Senshio (ospemifene) for the treatment of vulvar and vaginal atrophy

–          Zontivity (vorapaxar) for the reduction of atherothrombotic events.

–          Extensions of indications for Inductos and Travatan

–          Two new informed consent applications: Sevelamer carbonate Zentiva (sevelamer) for the control of hyperphosphataemia in adults receiving haemodialysis or peritoneal dialysis and Rasagiline ratiopharm (rasagiline) for the treatment of Parkinson’s disease.

–          A change in classification status from prescription to non-prescription for the emergency contraceptive ellaOne (ulipristal acetate).