Novartis Wins U.S. Approval For First MS Pill

Sept. 22 (Bloomberg) -- 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.

GO HERE to read more.