FDA Grants Orphan Drug Designation to Cevidoplenib for ITP
2024-03-21
临床2期孤儿药临床1期免疫疗法
PANGYO, South Korea, March 21, 2024 /PRNewswire/ -- Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its SYK inhibitorSYK inhibitor, Cevidoplenib, to treat immune thrombocytopenia (ITP).
Oscotec has successfully completed phase 2 study in patients with chronic ITP last year and are currently seeking partners for further development and global commercialization.
"Potential partners are drawing attention not only to the efficacy of cevidoplenib but also its exceptional safety profile and the convenience of oral dosing," said Dr. Taeyoung Yoon, CEO/CSO of Oscotec. "Obtaining ODD is an important milestone in the development of cevidoplenib and ultimately will benefit patients. We will explore every available option including partnership to deliver our drug as quickly as we can to those who suffers from the potentially crippling disease."
The orphan drug designation is granted to agents that prevent, diagnose, or treat a rare disease. Drug sponsors are eligible for incentives including tax credits for clinical trials, exemption from user fees, and a potential of 7 years of market exclusivity after approval.
Immune thrombocytopenia (ITP) is a disorder that can lead to easy or excessive bruising and bleeding. The bleeding results from unusually low levels of platelets. Formerly known as idiopathic thrombocytopenic purpura, ITP can cause purple bruises, as well as tiny reddish-purple dots that look like a rash. The prevalence (how many have ITP at any time) is 9.5 per 100,000. ITP patients experience chronic fatigue. The most concerning, but rare, form of bleeding due to ITP is an intracranial hemorrhage (bleeding in the brain). ITP treatment consists of the administration of corticosteroids, immunoglobulins, thrombopoietin receptor agoniststhrombopoietin receptor agonists, etc. However, sustained remission in the absence of treatment suggests the optimization of ITP management is necessary.
About Oscotec Inc.
Oscotec is a clinical stage drug discovery and development company pursuing translation of rigorous science into innovative medicine for clinically unmet needs.. The Company's clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2, completed) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1). The company is also the originator of Lazertinib (LECLAZA®), a 3rd generation EGFR inhibitorEGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers.
Contacts
Jihyun Park, IR/PR
[email protected]
SOURCE Oscotec Inc.
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