Biodexa receives orphan drug designation in europe for erapa in fap

May 12, 2025 biodexa receives orphan drug designation in europe for erapa in fap new designation follows the u.s. food and drug administration (fda) orphan drug designation for erapa in fap granted in 2019 company nears start of registrational phase 3 study targeted at an addressable market of $7.3bn biodexa pharmaceuticals plc (“biodexa” or the “company”) (nasdaq: bdrx), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the european commission (ec) has granted orphan drug designation for erapa in familial adenomatous polyposis (fap), a largely inherited precancerous disease of the colon for which there is currently no pharmaceutical intervention. ” this orphan drug designation is another important step as we move our fap program forward into a registrational phase 3 study.
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