Aldeyra Therapeutics Inc. on Thursday said it plans to seek speedy U.S. Food and Drug Administration approval of its ADX-2191 drug candidate for the treatment of primary vitreoretinal lymphoma, a rare but potentially fatal retinal cancer.
The Lexington, Mass., biotechnology company said the decision follows a pre-application meeting with the FDA, adding that it could submit its application as soon as the end of the year and that it will request priority review, which would shorten the agency's review period.
Aldeyra said ADX-2191 could be the first FDA-approved therapy for primary vitreoretinal lymphoma, which has a median survival of less than five years.
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