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FDA approves Novartis' oral MS drug

September 23, 2010 12:50 AM UTC

FDA approved Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN) to treat relapsing forms of multiple sclerosis (MS). The approval includes a REMS on the safe use and possible risks of Gilenya, which include slow heart rate, infections, macular edema and liver problems. Novartis said a doctor should take blood, vision, and liver tests before starting treatment and will monitor a patient's heart rate for six hours following the first dose of fingolimod. Novartis also said a second vision test should be administered three to four months after starting treatment. In addition, the pharma plans to begin a five-year safety study and a voluntary pregnancy registry. The company expects to launch the oral once-daily sphingosine 1-phosphate (S1P) receptor agonist on Oct. 4. In June, an FDA panel backed approval of Gilenya.

FDA said Gilenya is the first oral drug approved for relapsing forms of MS. FDA is also reviewing cladribine tablets from Merck KGaA (Xetra:MRK) for the indication, with a decision expected next quarter. Merck was down EUR 1.57 to EUR 70.65 on Wednesday. Ampyra dalfampridine, an oral sustained-release formulation of 4-aminopyridine from Acorda Therapeutics Inc. (NASDAQ:ACOR), was approved in January to improve walking ability in MS patients. Acorda was off $1.09 to $33.70 on Wednesday. ...