The USA's Alexion Pharmaceuticals has been given a likely thumbs-up from European health regulators for its blood disorder drug Soliris, the first product to win endorsement under a new European fast-track review process.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said that Soliris (eculizumab) had been recommended to treat paroxysmal nocturnal haemoglobinuria, a rare, disabling and life-threatening blood disorder defined by chronic red blood cell destruction. The positive opinion came following a review process lasting 147 days, just within the 150-day time limit of the rapid-review system.
At its usual end-of-month meeting, the CHMP also adopted positive opinions for Circadin (melatonin) from Neurim Pharmaceuticals for the short-term treatment of primary insomnia in patients aged 55 or older, and Invega (paliperidone), from Johnson & Johnson’s Janssen-Cilag unit for the treatment of
Negative opinion for Genasense, Cerepro
Faring less well was Genasense (oblimersen) from Genta, intended for the treatment of advanced or metastatic melanoma, which received a negative opinion from the CHMP, which also rejected Ark Therapeutics’ Cerepro (adenovirus-mediated Herpes simplex virus-thymidine kinase gene) for the treatment of patients with operable high-grade glioma.
Humira approved for Crohn’s in EU
In a busy meeting, the EMEA’s committee also extended the label on Abbott Laboratories’ rheumatoid arthritis drug Humira (adalimumab) to include treatment of adult patients with severe active Crohn’s disease. For more details on the CHMP’s latest list of positive and negative opinions, follow the links at www.emea.eu.int.