Novartis Wins U.S. FDA Approval for First MS Pill
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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.