Two of the three are gene therapies slated for an FDA decision by the end of the year, and the other is an experimental Alzheimer’s drug.
1. Exagamglogene autotemcel, a gene therapy candidate for treating severe sickle cell disease, received favor from FDA advisers in October. In a yearlong clinical trial, all patients avoided hospitalizations for vaso-occlusive crises. Drug regulators in the U.K. approved exa-cel in November, marking the world’s first approved CRISPR-based drug. The FDA plans to make its decision by Dec. 8.
2. Lovotibeglogene autotemcel is another gene therapy candidate indicated for severe sickle cell disease. A study found 96% of patients who received lovo-cel experienced no severe vaso-occlusive events after two years.
3. Donanemab is an intravenous drug that might be approved for mild Alzheimer’s disease and mild cognitive impairment due to Alzheimer’s. In a study, the drug candidate slowed disease progression by about 22% overall, and up to 60% slowed progression was found among those in early stages of the disease. The FDA is expected to make its decision in March.
Another therapy Optum Rx is watching is Zepbound (tirzepatide), an Eli Lilly weight loss drug the FDA approved in early November.
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