Approval of Gene Therapy Treatment for CALD Anticipated in September 2022

Lenti-D (elivaldogene autotemcel or eli-cel) is an investigational gene therapy being developed by bluebird bio for the treatment of childhood cerebral adrenoleukodystrophy (CALD). The FDA advisory committee reviewed it in June 2022 and unanimously approved drug/therapy 15-0. The FDA’s scheduled decision date on the therapy is September 16, 2022.

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Are You Ready? Preparing for Gene and Cell Therapies Coming Down the Pipeline

Gene and cell therapies can be life changing but come with expensive price tags. As more therapies are FDA approved, payers are looking for options to control the spiraling cost of specialty pharmacy and to project future financial risk related to new therapies coming to market.

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