LAVAL, QC and CAMBRIDGE, England, Sept. 21, 2020 /CNW Telbec/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (“FDA”) acknowledged receipt of the resubmission, by its US subsidiary, Prometic Biotherapeutics Inc., of the Biologic License Application (“BLA”) for Ryplazim® (plasminogen) for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency (“C-PLGD”) in pediatrics and adults. The FDA confirmed that the resubmission is a complete, Class 2 response and has provided a Prescription Drug User Fee Act (“PDUFA”) target action date of March 5, 2021.
Kenneth Galbraith, Chief Executive Officer of Liminal BioSciences.
Patrick Sartore, Chief Operating Officer – Plasma-Derived Therapeutics. “We are continuing our work to build awareness of congenital plasminogen deficiency with patient advocacy groups, physicians and payors to enable patient access in the US if Ryplazim® is approved by the FDA. In addition, we are exploring development and regulatory pathways in countries outside the US to seek marketing approval for Ryplazim® with potential third-party collaboration partners.”
the United States may be greater than these early epidemiological estimates. Congenital plasminogen deficiency may require lifelong therapy to avoid recurrence of lesions. There are currently no approved therapies for the treatment of congenital plasminogen deficiency.
September 4, 2020 with the FDA seeking approval to treat patients with congenital plasminogen deficiency. The PDUFA target action date for this BLA filing is March 5, 2021. Ryplazim® has previously been granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for the treatment of congenital plasminogen deficiency.
Winnipeg, Manitoba is licensed by the FDA and Health Canada, and is certified by the European Union and the Plasma Protein Therapeutics Association (PPTA). Our American center located in Amherst, New York is licensed by the State of New York and its BLA submission is currently under review by the FDA.
Canada, the United Kingdom and the United States.
the United States if approved, our regulatory and commercial plans for Ryplazim® outside the United States, the potential of our product candidates and development of R&D programs and the timing of initiation of clinical trials.
December 31, 2019 and future filings and reports by the Company, from time to time. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Liminal BioSciences’ business and the global economy. As a result, we cannot guarantee that any forward-looking statement will materialize. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. We assume no obligation to update any forward-looking statement contained in this Press Release even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.
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SOURCE Liminal BioSciences Inc.
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