FDA Grants Rare Pediatric Disease Designation to Omeros’ MASP-3 Inhibitor Zaltenibart for Treatment of C3 Glomerulopathy
OMER 10.24.2024
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Recent News
- 01.16.2025 - Omeros Announces Update on Statistical Analysis of Narsoplimab Pivotal Trial Primary Endpoint
- 12.19.2024 - Omeros’ Narsoplimab Meets its Pivotal Trial Primary Endpoint – Statistical Analysis Shows Survival Superiority Over External Control in Patients with TA-TMA
- 12.10.2024 - Omeros Corporation Announces Presentation of Positive Zaltenibart Data at ASH Annual Meeting
Recent Filings
--Phase 3 Studies on the Horizon in both PNH and C3G--
“C3G is devastating for children as well as for adults, and our receipt of FDA’s rare pediatric disease designation is a welcome acknowledgment of zaltenibart as a potential therapeutic for this disease that has no approved treatment,” stated Gregory A Demopulos, chairman and CEO of Omeros. “With zaltenibart clinical studies ongoing in both PNH and C3G and preparations underway to begin Phase 3 trials, we look forward to bringing zaltenibart to market, expanding its list of targeted indications and demonstrating its advantages over other alternative pathway inhibitors.”
Companies awarded a rare pediatric disease designation receive a rare pediatric disease priority review voucher from FDA when the designated drug is approved for the associated indication in the pediatric population. The voucher allows the recipient company to obtain FDA priority review of either a New Drug Application (NDA) or Biologics License Application (BLA) for a different product and/or indication, reducing the review time and accelerating any granted approval and subsequent market entry by at least four months. The voucher may be used by the original recipient, or it can be sold to another company for the purchaser’s use.
Omeros is also advancing zaltenibart for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare and life-threatening blood disease. Omeros has received orphan drug designation from FDA for zaltenitbart in this indication. Having recently held productive meetings with regulatory authorities – an end-of-phase 2 meeting with FDA and a scientific advice meeting in
About
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the
Forward-Looking Statements
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