On Friday, the FDA granted accelerated approval to lecanemab-irmb (Leqembi, Eisai R&D Management Co.) for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia. The accelerated approval pathway allows FDA to approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. Also on Friday, Eisai submitted the data from its successful phase 3 randomized controlled clinical trial (see last week’s New England Journal of Medicine or the Jan. 5 PNN) to support the conversion of the accelerated approval to a traditional approval. Lecanemab-irmb agent is the second humanized IgG1 monoclonal antibody that binds with high affinity to Aβ soluble protofibrils; the first was the controversial agent aducanumab.
The second most common SARS-CoV-2 subvariant currently circulating in the U.S., XBB.1.5 is expected to evade neutralization by Evusheld (tixagevimab co-packaged with cilgavimab), FDA said on Friday. The XBB.1.5 subvariant currently accounts for 28% of circulating variants in the U.S. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), the FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not protect against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. Healthcare providers should inform individuals of this increased risk for COVID-19 caused by nonsusceptible SARS-CoV-2 variants. If symptoms develop, people should seek medical attention, including starting treatment for COVID-19.