Lilly’s Solanezumab Reaches End Of Road As Donanemab Stays On Development Path
Last Study Of Soluble Amyloid-Clearing Antibody Fails
Solanezumab did not reduce the risk of progression in preclinical Alzheimer’s disease in the Phase III A4 study but it provided evidence that removing amyloid plaques – the mechanism of action for Lilly’s two remaining Phase III AD therapies, donanemab and remternetug – may be the key to efficacy.
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While a US FDA advisory committee would focus on efficacy and safety data from Leqembi’s Phase III CLARITY-AD trial, it likely also would provide a public forum for relitigating Audhelm’s accelerated approval and the evidence needed to formally validate amyloid plaque reduction as a surrogate.
Executives told Scrip the company is ready to move five programs into Phase III and launch five products this year, including an obesity indication for Mounjaro, but one drug has since received a CRL.
Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.