‘Priority’ for Alzheimer’s sBLA Seeking Traditional Approval
FDA has accepted for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is intended to support the conversion of the therapy’s 1/6 accelerated approval to a traditional approval for treating Alzheimer’s Disease (AD). The agency has set a user fee review action target date of 7/6, according to the companies, adding that an advisory committee meeting will be held prior to a review decision.
The companies say the submission is based on data from the CLARITY AD clinical trial that suggest treated patients with early Alzheimer’s disease had reduced brain amyloid levels and moderately less decline on clinical measures of cognition and function than patients on placebo at 18 months, but they experienced more serious adverse events than those on placebo. The data were presented by Eisai at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference in San Francisco 11/29/22, reporting that lecanemab treatment reduced clinical decline by 27% on the global cognitive and functional scale, compared with placebo. It also said treatment with lecanemab “showed statistically significant reduction in amyloid plaque burden at all timepoints starting at three months.”
Meanwhile, the Centers for Medicare & Medicaid Services (CMS) says it is not reconsidering its national coverage determination (NCD) that restricts Medicare coverage on AD monoclonal antibodies approved under FDA’s accelerated approval pathway. Currently, FDA has granted accelerated approval for Leqembi and the companies’ controversial Aduhelm (aducanumab-avwa). CMS reiterated its position in response to an Alzheimer’s Association request for reconsideration.
But there is some basis for optimism in CMS’ letter to the Alzheimer’s Association: it declared that if FDA “determines a clinical benefit for a drug within this class through its traditional approval program, CMS will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a registry-based study where the drug is tested in real-world settings.” CMS also said in an online statement that registry-based studies could answer clinical benefit questions and “potentially provide greater access nationwide at more treatment sites, more rapidly, than any other coverage pathway,” adding that the registry data could help fill evidence gaps for patients who were underrepresented in the initial clinical trials.