Novartis Gains FDA Approval for Gilenya Multiple-Sclerosis Drug

Novartis AG won U.S. regulatory approval to sell its multiple sclerosis medicine Gilenya, beating Merck KGaA in a race to market the first pill to slow the crippling disease.

The Food and Drug Administration 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 of Gilenya, 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 SA 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 today.

Current Therapies

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.

Novartis fell 1 Swiss franc, or 1.8 percent, to 55.45 Swiss francs at 5:30 p.m. in Zurich trading. Merck fell 1.57 euros, or 2.2 percent, to 70.65 euros in Frankfurt, the biggest drop since July 16.

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 U.S., said Koch, based on the price of the existing treatments, which ranges from $20,000 to $30,000.

Novartis changed the spelling of the pill’s name to Gilenya from Gilenia during the FDA’s review.

The review, initially set for six months, was delayed by three months when Novartis said May 25 that the FDA requested additional analysis of current 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.

European Approval

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

Multiple sclerosis causes the body to attack nerve cells through the immune system. Gilenya, known by the chemical name fingolimod, and cladribine blunt the attack by targeting white blood cells that harm the protective coating of nerve cells. Gilenya keeps lymphocytes, a type of white blood cell, from being released into the immune system, while cladribine works by killing lymphocytes.

Cladribine was cleared more than a decade ago to fight leukemia and has been approved as an MS treatment in Russia and Australia. Gilenya won approval in Russia on Sept. 10.

Three studies released this year showed both pills reduce the risk of relapses and worsening disease, with the Novartis drug also providing a greater benefit than an established interferon therapy in 12 months of treatment. Though the medicines work differently, both suppress the immune system, and patients who took the drugs had higher rates of infections including herpes and shingles.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net.

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Bloomberg reserves the right to edit or remove comments but is under no obligation to do so, or to explain individual moderation decisions.

Please enable JavaScript to view the comments powered by Disqus.