The use of casgevy for the treatment of tdt in the u.s Vertex has submitted a bla to the u.s Fda for the potential use of casgevy for patients 12 years and older with tdt and has been assigned a prescription drug user fee act (pdufa) target action date of march 30, 2024. Fda for the potential use of casgevy for patients 12 years and older with tdt and has been assigned a prescription drug user fee act (pdufa) target action. “on the heels of the historic fda approval of casgevy for sickle cell disease, it is exciting to now secure approval for tdt well ahead of the pdufa date,” said reshma kewalramani, m.d.,. Casgevy is under standard review in the u.s
Similar applications are being considered in the european union.
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