Novartis’ First MS Gets FDA Panel’s Backing

A US regulatory advisory panel’s backing for Novartis AG’s Gilenia, the first pill to treat multiple sclerosis, saw it rise in Zurich trading.

The panel advising the US Food and Drug Administration (FDA), voted unanimously in favour of the pill’s safety and effectiveness in a 21-3 vote yesterday, saying Novartis’s new drug Gilenia should be ‘generally recommended’ as an initial treatment for MS. FDA is not required to follow the panels’ recommendations, though it usually does, is scheduled to give its approval by September.

Switzerland-based Novartis and Merck KGaA are competing with each other to sell the first pill meant for delaying the progression of MS, a neurological disease affecting 2.5 million people worldwide. According to the National Multiple Sclerosis Society, a New York-based patient group, many of them have trouble staying with current therapies, as they are not only difficult to use, but also have side effects. Some of the current treatments comprise of injectable drugs, such as, Merck KGaA’s Rebif, Biogen Idec Inc.’s Avonex and Teva Pharmaceutical Industries Ltd.’s Copaxone.

Patricia O’Looney, Vice President for bio-medical research at the society, said the news was encouraging, as any treatment able to reduce relapses and slow disability progression in a convenient oral formulation could encourage more people with MS to begin treatment.

The news saw Novartis gain 1.65 Swiss francs or 3.1%, while Merck fell 77 cents or 1.3%, which analysts view as negative for Merck’s existing MS franchise, believing Rebif would likely lose market share.

The panel has voted 20 to 5 for a new study to test a 0.25 milligram Gilenia pill once a day, which FDA suggests may be far safer than the 0.5 milligram proposed daily dose, linked to heart, lung and liver risks and infections in studies. The panel voted the study could wait till after the drug was on the market, while Novartis said 2000 patients would be needed for testing a lower dose, which could take five to six years.

The panel also recommends taking the first dose of the drug under a doctor’s supervision to identify heart rhythm changes linked to initiating treatment, including additional testing for monitoring potential eye and lung risks.

Further, Merck informs resubmission of its application for marketing cladribine tablets to treat MS, which had been initially rejected by FDA in November, on the grounds of being incomplete.

Multiple sclerosis is a condition that causes the body to attack nerve cells via the immune system. Gilenia and cladribine by targeting white blood cells responsible for harming the protective coating of nerve cells, blunt the attack. Cladribine has been approved for treating leukaemia for over a decade.

Novartis bought the rights to Gilenia, chemically known as fingolimod in 1997 from Mitsubishi Tanabe Pharma Corp. of Osaka, who is helping it develop the drug in Japan.

The fact of it being an oral drug has experts predicting it will prove to be a blockbuster drug for Novartis, with annual sales of over $1 billion.