The June meeting was scheduled after expedited approval was denied.
The Food and Drug Administration (FDA) announced this week that it has scheduled a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the safety and effectiveness of Eli Lilly’s new Alzheimer’s drug, Donanemab.
The pharmaceutical company first submitted the drug to the FDA in January 2023, but its request for accelerated approval was denied. The company then submitted the drug to the FDA through the traditional approval process and originally expected FDA approval in early 2024.
The intravenous infusion was shown to be 35 percent more effective at slowing Alzheimer’s than a placebo during its 18-month-long clinical trials, but three out of 1,700 patients died from serious brain swelling. On June 10, the panel of outside professionals will discuss whether the benefits of Donanemab outweigh the risks.
As the Lord Leads, Pray with Us…
- For discernment for members of the PCNS committee as they review and evaluate Donanemab for the FDA.
- For Commissioner Califf and FDA personnel to be led by the Lord as they consider the authorization of medications and drugs for the treatment of various conditions and illnesses.
Sources: The Hill, Business Insider
