Lecanemab

Sage Therapeutics cuts staff, Eisai/Biogen's Leqembi rejected in Australia, Sanofi invests in Orano Med, Novartis licenses Chinese cancer treatment, telehealth's GLP-1 boom driven by select doctor groups, former Trump official calls for IRA revisit, BMS CEO discusses company pivot, Lilly CSO warns against weakening patents, GLP-1s linked to lower opioid overdose risk, Novavax faces vaccine setback.

Australia's TGA won't approve Eisai and Biogen's Alzheimer's therapy Leqembi, citing insufficient efficacy and safety risks like ARIA. Eisai Australia plans to request a reconsideration. Leqembi is already approved in the US, Japan, China, and other countries.

Concerns over Alzheimer’s drug donanemab (Kisunla) approval include lack of transparency, underreporting of side effects, and advisory panel replacements. Critics argue for stricter FDA oversight and caution against industry influence on patient advocacy groups.

BMJ investigation reveals 8 of 11 FDA advisory committee members had ties to Kisunla's maker Eli Lilly, raising concerns over conflicts of interest in drug approval processes. Despite this, the committee unanimously recommended Kisunla's approval, sparking debate on the influence of financial ties on expert decision-making and public trust in the FDA.

A study in JAMA Internal Medicine suggests that introducing a 75-mg vial size for Leqembi could save US Medicare millions annually by reducing drug waste, as current 500 mg and 200 mg vials often exceed prescribed doses.

Introducing a 75-mg vial size for Leqembi could save Medicare up to $336 million annually by reducing drug waste, as current vial sizes often exceed prescribed doses, leading to significant discard.

A tweak in vial sizes of Alzheimer’s drug Leqembi could save Medicare $336 million annually by reducing waste from leftover doses.

FDA grants Biogen's monoclonal antibody felzartamab breakthrough therapy designation for treating late antibody-mediated rejection in kidney transplant patients, based on positive Phase II trial data. Biogen plans to initiate Phase III trials for felzartamab in multiple indications next year. The therapy, acquired through the $1.15bn HI-Bio acquisition, is expected to generate over $776m by 2032 if approved.

Alzheimer's disease research saw a decade of stagnation until FDA approved aducanumab in 2021. Since then, therapies like donanemab and lecanemab have shown promise. NKGen's SNK01, an NK cell therapy, and Longeveron's Lomecel-B, an MSC therapy, are in phase 2 trials, demonstrating efficacy and safety. Other novel therapies, including Biogen's BIIB080 and AAV2-BDNF gene therapy, are also in development.