USFDA grants ODD to Cevidoplenib for immune thrombocytopenia

Oscotec has successfully completed phase 2 study in patients with chronic ITP last year

Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its SYK 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.