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FDA grants orphan drug designation to ALM201 for ovarian cancer
The FDA granted orphan drug designation to ALM201 for the treatment of ovarian cancer, according to the agent’s manufacturer.
ALM201 (Almac Discovery) is a therapeutic peptide developed to imitate properties of the FKBPL protein, a naturally secreted protein that has effects on multiple tumor biology processes, including cancer stem cells and angiogenesis.
“The FDA’s orphan drug designation of ALM201 in the treatment of ovarian cancer will allow for valuable assistance from the FDA during clinical development for either ourselves or our partners for this difficult-to-treat patient population,” Stephen Barr, PHD, managing director and president of Almac Discovery, said in a company-issued press release.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.