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Ryplazim FDA Approval History

Last updated by Judith Stewart, BPharm on June 16, 2021.

FDA Approved: Yes (First approved June 4, 2021)
Brand name: Ryplazim
Generic name: plasminogen, human-tvmh
Dosage form: Injection
Company: Liminal BioSciences Inc.
Treatment for: Plasminogen Deficiency Type 1

Ryplazim (plasminogen, human-tvmh) is a plasma-derived plasminogen replacement therapy for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia).

  • Ryplazim works by temporarily increasing plasminogen levels in the blood.
  • Ryplazim is administered via intravenous infusion over 10-30 minutes every 2 to 4 days.
  • Common adverse reactions include abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain.

Development timeline for Ryplazim

DateArticle
Jun  4, 2021Approval FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1
Nov  8, 2020Liminal BioSciences Announces FDA Extension of Review Period for Ryplazim (plasminogen) BLA
Sep 21, 2020Liminal BioSciences Provides Update on Progress on BLA for Ryplazim (plasminogen)
Sep  8, 2020Liminal BioSciences Announces Resubmission of Biologics License Application to U.S. Food and Drug Administration for Ryplazim (plasminogen)

Further information

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