CHMP backs Novartis' Gilenya as EMA shoots down cladribine

Novartis' Gilenya success continues. The EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of the drug to treat multiple sclerosis. The CHMP ruling will be taken into account when the European Commission licensing decision, which is expected in three months.

The FDA has already approved the drug in the U.S. following a unanimous expert panel vote in favor of the treatment. It's the first oral drug to compete in the $11 billion a year MS therapy market and analysts expect peak sales to hit $3.5 billion annually, given its approval as a first-line therapy.

"More than 500,000 people in the EU live with MS, a debilitating neurological condition that involves an unpredictable, life-long progression of complex symptoms," commented John Golding, president, European Multiple Sclerosis Platform. "The first available oral MS treatment that offers significant efficacy for appropriate patients is a welcome alternative."

- here's the Novartis release
- read the Bloomberg article for more

ALSO: The EMA confirmed the CHMP's negative opinion of Merck KGaA's oral MS drug cladribine, saying that the pill's benefits don't outweigh the risks. The company plans to complete ongoing trials of the drug and reapply for approval in the future. The treatment has only been approved in Australia and Russia, and is still awaiting an FDA decision in the U.S. Report

PLUS: While Novartis was getting good news for its MS drug, the CHMP was not as kind to Biogen Idec. Experts recommended against approval of Fampyra, which is intended to improve MS patients' ability to walk (but not to treat the disease itself). The panel determined Fampyra's side effects did not outweigh potential benefits for patients. Report