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Pharming announces positive interim analysis data from open-label extension study of leniolisib in presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition

Clinical trials

V. Koneti Rao, MD, shared new evidence of long-term safety and hematologic response in patients who received leniolisib to treat APDS, a rare primary immunodeficiency. Interim analysis demonstrated leniolisib to be well tolerated and indicated the durability of the efficacy results seen in the Phase II/III randomized, controlled trial

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Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib

Operational updates

Pharming Group N.V. announces that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adults and adolescents 12 years or older.

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