WASHINGTON (dpa-AFX) - HUTCHMED (China) Limited (HCM) announced that the U.S. FDA has granted Orphan Drug Designation to Sovleplenib, an oral drug being developed to treat primary immune thrombocytopenia, a rare autoimmune disorder that increases the risk of bleeding.
The designation recognizes the potential of Sovleplenib to address unmet medical needs in people with this condition. It also makes the drug eligible for certain development incentives, including seven years of U.S. market exclusivity if it receives FDA approval for the designated indication.
About Primary immune thrombocytopenia
Primary immune thrombocytopenia (ITP) is an autoimmune disorder in which the immune system destroys platelets and reduces their production. Platelets help blood clot, so people with ITP may experience excessive bruising and bleeding. The condition can also cause fatigue and affect quality of life.
Although several treatments are available, the disease can persist for years, and treatment does not always provide a lasting response. Some patients develop resistance to existing therapies or experience a relapse, creating a need for additional treatment options.
According to HUTCHMED, approximately 56,000 people across the U.S., Germany, France, Italy, Spain, the U.K. and Japan are estimated to be living with primary ITP. The company also estimates that around 110,000 people in China have the condition.
About Sovleplenib
Sovleplenib is a selective inhibitor of Syk (spleen tyrosine kinase), designed for once daily oral administration. Syk plays a role in immune-cell signalling, including pathways involved in platelet destruction in ITP. By inhibiting this protein, Sovleplenib is being developed as a potential treatment approach for the disorder.
The FDA's Orphan Drug Designation program applies to drugs and biologics intended to treat, diagnose or prevent rare disease affecting fewer than 200,000 people in the U.S. In addition to potential seven-year market exclusivity upon approval, the designation may provide incentives such as tax credits for eligible clinical trials, waivers of certain FDA user fees and specialized regulatory guidance during development.
Regulatory Status in China
HUTCHMED said new drug applications for Sovleplenib are under review by China's National Medical Products Administration (NMPA) for primary ITP and warm antibody autoimmune hemolytic anemia. The applications are supported by positive data from the pivotal ESLIM-01 and ESLIM-02 trials, respectively.
HUTCHMED retains worldwide rights to Sovleplenib.
HCM has traded between $9.77 and $16.33 over the past year. The stock closed Wednesday's trading at $13.32, down 3.48%. During overnight trading session the stock is at $13.42, up 0.75%.
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