FDA Panel, collectively voted for Novartis, pill for multiple sclerosis. Novartis is safe and effective , and is a hug boost for the drugmaker. Wall Streets estimates Gilenia can generated a $1 billion or more annually. Food and Drug Administration advisory panel backed the drug to help reduce and delay patients’ symptoms.
The FDA’s outside advisers said that despite some concerns over potential risks the drug worked well enough to be considered an initial treatment option for all MS patients. They said that more data is still needed, especially on side effects.
The FDA will weigh the panel’s recommendation as it makes its approval decision, expected by September. If approved, Novartis’ Gilenia could be the first pill to treat U.S. patients, whose options now are limited to more invasive, injectable medications.
The vote came despite speculation over safety concerns. Clinical trials showed a drop in heart rates, declining lung function, macular edema and liver abnormalities, as well as links to certain cancers. Nonetheless, the convenience of a pill that is deemed effective and safe – certainly in relation to a disease for which patients need additional options – was seen as desirable (background).
The panel of 25 non-FDA medical experts must still vote on whether Gilenia should be reserved for use to treat MS patients after first trying other drugs.
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