Oral medication for relapsing MS approved by FDA

From The Boston Globe:

Swiss pharmaceutical company Novartis won approval from the Food and Drug Administration Sept. 22 to sell its multiple sclerosis medicine Gilenya, beating Merck in a race to market the first pill to slow the crippling disease.

The FDA cleared the treatment for use against relapsing forms of multiple sclerosis, the Basel, Switzerland-based company said in a statement. A doctor will have to watch patients for six hours after their first dose, Novartis said. Regulators also recommend checking patients’ blood and eyes before treatment, a demand less restrictive than expected, said Karl-Heinz Koch, an analyst at Helvea in Zurich.

“We were like ‘Wow,’ ’’ Koch said in a telephone interview. “This is a very good outcome for Novartis. They’ll really be able to stir up the MS market.’’ Koch said he now believes Gilenya can achieve double his estimate of $1.4 billion in peak annual sales.

Regulators said doctors can prescribe the drug as the first treatment for MS patients, making it competitive with standard drugs such as Biogen Idec Inc.’s Avonex, Merck’s Rebif, and Teva Pharmaceutical Industries Ltd.’s Copaxone. The drug “certainly has multibillion potential,’’ Trevor Mundel, Novartis’s head of drug development, said in a telephone interview yesterday.

Multiple sclerosis affects 2.5 million people worldwide, many of whom have trouble sticking with current therapies because they’re difficult to use or have side effects, according to the National Multiple Sclerosis Society, a New York-based patient group.

In a press release yesterday, Biogen Idec said: “MS impacts each person differently, and until we have a cure, there should be multiple treatments available to address the individual needs of patients. Today Biogen Idec is pleased to provide leading MS therapies Avonex (interferon beta-1a) and Tysabri (natalizumab), both of which have been used in a broad range of patients worldwide.’’

The Weston, Mass., firm added: “The long-term safety profile of Gilenya has yet to be established, and . . . We agree with the FDA that there is a need for safety monitoring for Gilenya through a comprehensive Risk Evaluation and Mitigation Strategy.’’

Shares of Biogen Idec declined yesterday, falling $3.37 to $54.86. Novartis shares fell 29 cents to $56.17 on the New York Stock Exchange.

A Novartis spokesman didn’t immediately return a call seeking comment on the price of the drug. Gilenya probably will cost about $30,000 a year in the United States, said Koch, based on the prices of the existing treatments, which range from $20,000 to $30,000.

The review, initially set for six months, was delayed by three months when Novartis said May 25 that the FDA requested additional analysis of data. Rival medicine cladribine, from Darmstadt, Germany-based Merck, won a priority review in July, reducing to six months from 10 the time it will take the FDA to decide on approval, after the agency rejected an earlier application in November. Merck expects a decision on cladribine in the fourth quarter.

Novartis expects European regulators to decide on Gilenya’s approval within six months. The European approval is “on track,’’ Mundel said.

Novartis also has a presence in Massachusetts. Its Institutes for BioMedical Research is in the Kendall Square neighborhood of Cambridge.