Brief: Pharming Submits Marketing Authorisation Application To The EMA For Leniolisib

Pharming

11/10/2022 06:07

Oct 11 (Reuters) - Pharming Group NV  PHAR.AS :
    * PHARMING SUBMITS A MARKETING AUTHORISATION APPLICATION TO
THE
EUROPEAN MEDICINES AGENCY FOR LENIOLISIB
    * THIS SUBMISSION FOLLOWS GRANT OF ACCELERATED ASSESSMENT
ALLOWING
AN EXPEDITED REVIEW FOR LENIOLISIB FROM A STANDARD 210 DAYS TO
150 DAYS
    * APPLICATION IS BASED ON RANDOMIZED, CONTROLLED AND
LONG-TERM
EXTENSION DATA FOR LENIOLISIB AS A TREATMENT FOR APDS, A RARE
PRIMARY IMMUNODEFICIENCY
    * MARKETING AUTHORISATION FOR LENIOLISIB IN EEA IS
ANTICIPATED IN
H1 2023.

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