Brief: FDA Approves First Gene Therapies To Treat Patients With Sickle Cell Disease

Crispr Therapeutics AG

08/12/2023 16:20

Dec 8 (Reuters) - FDA:
    * FDA APPROVES FIRST GENE THERAPIES TO TREAT PATIENTS WITH
SICKLE
CELL DISEASE
    * FDA:  APPROVED CASGEVY AND LYFGENIA, REPRESENTING FIRST
CELL-BASED GENE THERAPIES FOR TREATMENT OF SICKLE CELL DISEASE
IN PATIENTS 12 YEARS AND OLDER
    * FDA: GRANTED APPROVAL OF CASGEVY TO VERTEX PHARMACEUTICALS
INC.
AND APPROVAL OF LYFGENIA TO BLUEBIRD BIO INC
    * FDA - PATIENTS WHO RECEIVED CASGEVY OR LYFGENIA WILL BE
FOLLOWED
IN A LONG-TERM STUDY TO EVALUATE EACH PRODUCT’S SAFETY AND
EFFECTIVENESS
    * FDA- A BLACK BOX WARNING IS INCLUDED IN THE LABEL FOR
LYFGENIA
WITH INFORMATION REGARDING RISK OF HEMATOLOGIC MALIGNANCY
    * FDA- PATIENTS RECEIVING LYFGENIA SHOULD HAVE LIFELONG
MONITORING
FOR MALIGNANCIES

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 ((Reuters.Briefs@thomsonreuters.com;))