After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease med Kisunla (donanemab) also got a rejection from EU regulators.
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against a marketing authorization for the drug’s use in early symptomatic Alzheimer’s disease. The agency argued that the benefits of the treatment “were not large enough” to outweigh the risk of potentially fatal events such as swelling and bleeding of the and brain, a side effect known as amyloid-related imaging abnormalities (ARIA).
Lilly will seek a re-examination of the decision. The company hopes to “continue our discussions with the agency to bring donanemab to the millions of people across Europe suffering from this relentless, fatal disease,” EVP and president of Lilly International Ilya Yuffa said in a company statement Friday.
The drugmaker “remains confident in the safety and effectiveness of donanemab,”
As Eisai and Biogen can attest, European regulators are cautious about the safety concerns of Alzheimer’s drugs. The partners’ Kisunla-rivaling Leqembi eventually won CHMP’s favor in February, albeit in a restricted patient population of those with mild Alzheimer’s-related cognitive impairment or dementia who carry one or no copies of the ApoE4 gene.
The positive opinion there came after the regulator first denied the treatment, citing benefits that “do not counteract the risk of serious adverse events” such as ARIA. The ARIA safety risk is greater in those who have two copies of the ApoE4 gene.
Over in England, NICE recently declined to recommend both of the Alzheimer’s drugs for coverage in the region’s National Health Service for the second time, despite both winning approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). The agency cited a review from an independent committee on additional clinical data that ultimately confirmed that the medicines “are not currently cost effective.”
In the U.S., both Kisunla and Leqembi are FDA-approved with a black boxed warning label for ARIA risk.
Meanwhile with CHMP, several other drugmakers such as Bristol Myers Squibb received good news. The committee issued a positive opinion on the company’s subcutaneous formulation of blockbuster oncology drug Opdivo, clearing the way for an EU approval. Seven drugs—including AstraZeneca’s Calequence, Johnson & Johnson’s Tremfya and Seqirus’ flu vaccine Flucelvax—won label extensions, while Incyte’s Pemazyre was not recommended for one.
The committee also wrapped up its review of Orexigen Therapeutics’ Currax-partnered weight loss med Mysimba, which was being evaluated again due to concerns of potential long-term cardiovascular risks. While CHMP determined that the benefits of the drug outweigh the risks, the company must provide more information on long-term use through an ongoing study that should wrap up in 2028.
Since the available data only shows that there are no safety concerns when Mysimba is used for up to 12 months, the committee warned that treatment should be stopped after one year if weight loss of at least 5% of initial body weight isn’t maintained, and that doctors should closely monitor a patient’s yearly progress on the med. The drug was first approved in Europe in 2015.