immune thrombocytopenia

Hutchmed Initiates P-III ESLIM-01 Trial of HMPL-523 for the Treatment of Immune Thrombocytopenia in China

Shots: The company has initiated a P-III ESLIM-01 trial to evaluate the efficacy and safety of HMPL-523 in 180 adult patients with ITP. The study is based on the results of the P-Ib study in patients with the same indication The 1EPs of the study is the DRR. The 2EPs and exploratory EPs include ORR, …

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Sobi gets EU nod for Doptelet in rare blood disorder ITP

Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the drug. Doptelet (avatrombopag) – an oral thrombopoietin receptor agonist – has been cleared to boost depleted levels of platelets in the blood of patients with ITP, an autoimmune clotting disorder …

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FDA to expedite development of two Sanofi rare disease drugs

The FDA has agreed to expedite development of two rare disease drugs from Sanofi. The most significant of the two announcements is the Priority Review for avalglucosidase alfa, a potential new therapy for Pompe disease. The review period will be shortened from the standard ten months to six months or less, and the French pharma …

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