FDA Advisors Cleared a Path for New Gene Therapies in 2022 | MedPage Today (Abomination Shot Adverse Events)

Stew Peters and Karen Kingston- Nanobotshttps://rumble.com/v234n8u-live-jab-induced-cancer-rates-surging-mikovits-and-kingston-expose-premedit.html


Earlier this year, MedPage Today reported on an FDA advisory committee meeting in which it was unanimously recommended that two gene therapies be approved — betibeglogene autotemcelopens in a new tab or window (beti-cel, Zynteglo) for patients with transfusion-dependent beta-thalassemia, a chronic inherited blood disorder; and elivaldogene autotemcel (eli-cel, Skysona) for select children with cerebral adrenoleukodystrophy (CALD). As part of our review of the year’s top stories, we follow up on what has happened since the panel’s vote


In June, by a vote of 13-0, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recommended approval of beti-cel for adult and pediatric patients with transfusion-dependent beta-thalassemia. The committee enthusiastically backed the therapy based on reports from two phase III trials in which 89% of patients achieved transfusion independence, with stable hemoglobin levels observed up to 7 years later.


At the June meeting, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee also unanimously backedopens in a new tab or window eli-cel for select children with CALD — a neurologically debilitating form of the disease that usually occurs in boys — arguing that the benefits outweigh the risks (including the possibility of malignancy).

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