(ABM FN-Dow Jones) Pharma gets fast-track review of leniolisib in US after FDA accepts Dutch biotech’s application Pharming made the announcement on Wednesday.
The FDA has set the target date for the Prescription User Fee Act as March 29, 2023.
Farming filed the application on July 29 this year. That use was supported by positive data from a phase II/III clinical trial with lenolisib, which met the co-primary endpoints of reduction in index lymph node volume and recovery from immunodeficiency in the target population.
At the half-year results, CEO Sijmen de Vries told ABM Financial News that he expects first sales of leniolisib in the US by the end of the second quarter of 2023 if the FDA approves the accelerated procedure.
Lenolicip is an oral selective phosphoinositide-3-kinase-delta (PI3Kd) inhibitor for the treatment of activated phosphoinositide 3-kinase-delta syndrome (APDS), a rare immune system disorder in adults and adolescents aged 12 years and older. United States of America
Source: ABM Financial News
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