Research & Development
Pharming Group's leniolisib Marketing Authorisation Application receives European regulator's accelerated assessment
1 August 2022 -

Pharming Group NV (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR), a Netherlands-based global biopharmaceutical company, announced on Monday that it has received an accelerated assessment for the Marketing Authorisation Application (MAA) for leniolisib from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

The product is intended to treat activated PI3K delta syndrome (APDS), a rare primary immunodeficiency, in adults and adolescents age 12 or older in the European Economic Area (EEA). It is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating and potentially anti-neoplastic activities. It inhibits the production of phosphatidylinositol-3-4-5-trisphosphate (PIP3)

The company is on track and is planning to submit its MAA for the product to the EMA in October 2022.

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