Novartis will make case to FDA for approving pill-based multiple sclerosis treatment

By AP
Tuesday, June 8, 2010

SUMMARY BOX: Novartis’ multiple sclerosis drug

Novartis is moving closer to marketing a pill-based drug for multiple sclerosis, though a federal review released Tuesday underscored safety concerns with the medication.

NEW OPTION: Currently all the drugs used to treat the disease are injectables. Novartis’ Gilenia would be the first pill for the disease.

SAFETY CONCERNS: FDA staff noted side effects with the drug, including eye disorders, heart problems and weakened lung function.

EXPERT OPINION: On Thursday the FDA will ask a panel of outside advisers to vote on whether Gilenia should be approved. The FDA is not required to follow the group’s advice, though it usually does.

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