Europe gives green light to new Novartis, Alexion drugs

Saturday, Jun 27, 2015

New drugs from Novartis and Alexion won a green light from European regulators on Friday, delivering a boost to both drugmakers and offering new treatment options for cancer and rare diseases.

Experts from the European Medicines Agency (EMA) said they had recommended approval of Novartis's Farydak for multiple myeloma, an aggressive blood cancer, and Odomzo for basal cell carcinoma, a type of skin cancer.

Farydak won U.S. approval in February.

Alexion, which specialises in high-priced drugs for niche diseases, won a recommendation for two enzyme replacement medicines for rare metabolic diseases known as Strensiq and Kanuma. Alexion acquired the latter product after buying Synageva earlier this year.

Santhera Pharmaceuticals had announced that its Raxone drug had also won a positive recommendation for treating Leber's hereditary optic neuropathy.

Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.