What We’re Reading: FDA Delays Decision on Donanemab; Weight Loss Drug Costs; Effective RSV Treatment

FDA Delays Approval of Eli Lilly’s Alzheimer’s Drug

Eli Lilly announced Friday that the FDA has pushed back its approval deadline for donanemab, the company's experimental Alzheimer’s treatment, according to CNBC. The drugmakers explained that the FDA plans to call a last-minute meeting of its outside advisors to further review the drug’s safety and efficacy in a late-stage trial. The FDA has not disclosed the meeting date, so a potential approval would likely come after this month. Initially, the FDA was expected to decide on donanemab by the end of the first quarter, with the deadline already delayed from an expected approval last year. In a press release, Eli Lilly called the delay “unexpected,” but noted that it is confident in donanemab’s potential benefits to patients with early symptomatic Alzheimer’s disease.

Cigna to Help Health Plans Limit Weight-Loss Drug Costs

As demand for weight-loss drugs soars, Cigna announced the launch of a program on Thursday aimed at capping annual cost increases of these treatments for health insurance providers and employers at 15%, according to Reuters. The high demand for weight-loss drugs like Wegovy and Zepbound has led to increased costs for employer-sponsored health insurance in recent months. Consequently, a spokesperson claimed that Evernorth, Cigna’s pharmacy benefit management unit, will guarantee its clients a limit in annual increases in weight-loss drug costs at 15% by helping those with obesity and diabetes instead through lifestyle modification and coaching support. The company claimed that this would help ensure access to the drugs for appropriate patients as it is the “industry’s first financial guarantee” for clients interested in covering weight-loss drugs mimicking the GLP-1 hormone.

RSV Shot Effective at Preventing Hospitalizations in Children

New data published in the CDC’s Morbidity and Mortality Weekly Report showed that nirsevimab (Beyfortus), a recently FDA-approved monoclonal antibody product to protect young children against respiratory syncytial virus (RSV), was 90% effective at preventing children from being hospitalized with the virus, according to Stat. The analysis is based on data from the CDC’s New Vaccine Surveillance Network, which looked at RSV hospitalizations from the beginning of October through the end of February. Pooled data from clinical trials suggested nirsevimab was 79% effective at preventing infections that were serious enough to require medical care and 81% effective at preventing hospitalizations due to RSV in the 150 days after administration. Conversely, the authors cautioned the effectiveness of nirsevimab would likely decline throughout RSV season as the antibodies it contains degrade over time.