Liminal BioSciences announces resubmission of biologics license application to U.S. FDA for Ryplazim (plasminogen)

Liminal BioSciences

8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and reduction in lesion size.

Liminal BioSciences today announced that the Company, through its U.S. subsidiary Prometic Biotherapeutics, has filed a resubmission of the biologics license application for Ryplazim (plasminogen) with the U.S. FDA for the treatment of congenital plasminogen deficiency.

In 2017 the Company received a complete response letter in response to a BLA submission for Ryplazim. The Company believes that the resubmission addresses the deficiencies outlined in the letter, which were related to certain manufacturing procedures.

Read Liminal BioSciences press release

Michael Wonder

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Michael Wonder

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US , Dossier , Blood product