Brief: Hansa Biopharma Announces Positive Early Access Decision By French Haute Autorité De Santé To Use Idefirix as desensitization treatment for highly sensitized kidney transplant patients

Hansa Biopharma AB

25/02/2022 22:54

Feb 25 (Reuters) - Hansa Biopharma AB  HNSA.ST :
    * HANSA BIOPHARMA ANNOUNCES POSITIVE EARLY ACCESS DECISION
BY
FRENCH HAUTE AUTORITÉ DE SANTÉ TO USE IDEFIRIX (IMLIFIDASE) AS
DESENSITIZATION TREATMENT FOR HIGHLY SENSITIZED KIDNEY
TRANSPLANT PATIENTS
    * COMMERCIAL LAUNCH ACTIVITIES FOR IDEFIRIX® IN EUROPE
CONTINUE TO
PROGRESS
    * DECISION TO USE COMMERCIALLY SUPPLIED
IDEFIRIX®(IMLIFIDASE) IN
APPROVED INDICATION BY EUROPEAN MEDICINES AGENCY (EMA)
    * EFFICACY AND SAFETY OF MEDICINAL PRODUCT ARE STRONGLY
PRESUMED
BASED ON RESULTS OF CLINICAL TRIALS
    * APPROVAL OF THIS EARLY ACCESS PROGRAM FOR IDEFIRIX IS
VALID FOR
YEAR FROM DATE OF DECISION, FUNDED THROUGH NATIONAL SECURITY
SYSTEM

Source text for Eikon:  ID:nWkr4nxhkc 
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