Lecanemab

Innovation in neuropsychiatry is reviving with approvals like Bristol Myers Squibb’s Cobenfy and Sage Therapeutics’ Zurzuave. Challenges include costly Phase III trials and lack of effective animal models for CNS disorders. Investment in neuroscience is cyclical, with unclear causality and biomarkers. Biogen’s Aduhelm and Eisai’s Leqembi highlight the complexities of launching treatments in neurodegenerative diseases. Early diagnosis and targeted patient selection are crucial, with AI and blood-based biomarkers offering potential solutions. Psychedelics show promise in neuropsychiatry, though regulatory and public perception hurdles remain. The field faces challenges due to the lack of biological biomarkers, but functional improvements and quality-of-life gains drive optimism and investment.

Alzheimer's researchers at the 2024 CTAD conference discussed the future of treatment, focusing on combination therapies, reducing ARIA risk, and novel approaches like gene therapy and stem cell treatment. Key topics included the potential of anti-amyloid antibodies in combination with other therapies, efforts to lower ARIA risk, and the presentation of promising data from gene therapy and stem cell studies.

An 80-something patient with normal cognitive tests for 10 years received a positive Alzheimer’s biomarker test, causing panic. The test indicates increased risk, not an early stage of the disease. The medical community’s urgency to classify positive biomarkers as “Stage One Alzheimer’s” is potentially harmful, causing unnecessary stress. Biomarker tests should only be considered if there are noticeable cognitive symptoms, and lifestyle changes can improve cognitive function. Widespread testing should be avoided until better predictive tools and treatments are available.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

Eisai reduces Leqembi sales forecast to JPY 42.5 billion from JPY 56.5 billion due to sluggish uptake. The drug, partnered with Biogen, faces regulatory setbacks in EU and Australia and reimbursement issues. Eisai hopes new formulations and the AHEAD 3-45 trial results will boost sales.

Since Leqembi's approval in 2023, neurologists have learned: 1) it takes 5 months on average to start treatment; 2) Black and Hispanic Americans are underrepresented; 3) most U.S. infusions occur in urban centers; 4) Japan treats more patients with fewer ARIA cases; 5) blood tests aren't yet adequate for confirming Alzheimer's biomarkers.

BrightSpring Health Services announces CareMed selected as national specialty pharmacy partner for Leqembi®, an FDA-approved Alzheimer's treatment showing efficacy in slowing cognitive decline over 18 months in Phase III trials.

Cassava Sciences is advancing simufilam through a phase 3 trial, despite SEC controversy over past data integrity. The company aims to release trial results soon, with new leadership emphasizing transparency and ethical practices. The success of simufilam, Cassava's only asset, hinges on these results, which will face heightened scrutiny due to previous data issues.

Cognition Therapeutics presented data from its Phase II SHINE trial showing CT1812 significantly slowed cognitive decline in mild-to-moderate Alzheimer’s patients with low baseline plasma p-tau217 levels, with 95% slowing measured by ADAS-Cog 11 and 108% by MMSE. The company plans to discuss Phase III with the FDA in 2025, considering subgroup recruitment strategies and dosing, while facing funding challenges.

The Korean Dementia Association reassures on Leqembi's safety, noting rare side effects like brain hemorrhage. Phase 3 trial results show Leqembi delayed Alzheimer’s progression by 27%, leading to MFDS approval in Korea. Despite EU and Australia's refusal to approve due to ARIA concerns, Korean data reveals fewer side effects in Asians, with only 6.5% incidence of cerebral edema among Korean participants.