Serious concerns about manufacturing quality extended the US Food and Drug Administration’s fast-track review of Prometic Biotherapeutics Inc.’s designated orphan drug, Ryplazim (plasminogen, human-tvmh), by more than three years while the company developed a new manufacturing process.
The biologic drug product, which the FDA licensed 4 June, addresses an unmet medical need by providing plasminogen purified from human plasma to people who have a type of genetic plasminogen deficiency that causes them to develop ligneous lesions, according to the agency’s
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