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2022

Pharming Announces New ICD-10-CM Code for APDS, a Rare Primary Immunodeficiency

Operational updates

Pharming Group N.V. announces that a new diagnosis code for reporting cases of activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, will be added to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) by the US Centers for Disease Control and Prevention (CDC). The diagnosis code, D81.82 ‒ Activated Phosphoinositide 3-kinase Delta Syndrome (APDS), will be effective starting October 1, 2022.

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Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS

Operational updates

Pharming Group N.V. announces that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for the Marketing Authorisation Application (MAA) for leniolisib. Leniolisib has been studied for the treatment of activated PI3K delta syndrome (APDS), a rare primary immunodeficiency, in adults and adolescents age 12 or older in the European Economic Area (EEA). Pharming is on track and plans to submit its MAA for leniolisib to the EMA in October 2022.

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Pharming receives agreement of Paediatric Investigation Plan and Promising Innovative Medicine designation for leniolisib from UK MHRA

Operational updates

An agreed Paediatric Investigation Plan (PIP) is the regulatory pathway to market authorization for leniolisib as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children. A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA’s Early Access to Medicines Scheme

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2021

Pharming Group and Sanofi renew strategic manufacturing partnership agreement

Operational updates

Pharming announces that it has renewed its strategic manufacturing partnership with long-term manufacturing partner Sanofi S.A. The extended 5-year contract which includes options for extensions, ensures the continuation of the downstream processing in the production of RUCONEST®, a recombinant C1 inhibitor product approved for the acute treatment of hereditary angioedema.

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