An FDA advisory panel unanimously voted that a Novartis pill for multiple sclerosis is safe and effective, which is a big boost for the drugmaker. Wall Streets estimates Gilenia can generated a $1 billion or more annually.
The panel did recommend the FDA require Novartis conduct a study at a lower dose than the 0.5 mg proposed, but not as a requirement for agency marketing approval, The Wall Street Journal reports. This is crucial for Novartis, because an additional study requirement prior to FDA approval would delay approval for months, at the least.
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.