The Food and Drug Administration on Tuesday granted approval to a closely watched Alzheimer’s drug, concluding that the benefits of modestly slowing progression of the devastating disease outweigh its risks, drugmaker Eli Lilly announced.

The agency, in a surprise move in March, had delayed approval of the drug, known as donanemab, to further scrutinize the drug’s safety and effectiveness. Last month, a panel of independent experts unanimously endorsed the drug, setting the stage for the FDA’s sign off.

Eli Lilly’s drug is one of the few treatments developed for Alzheimer’s that modifies the underlying disease and will join just one other, Leqembi, on the commercial market. The drug – which was approved for treatment of early symptomatic Alzheimer’s disease – doesn’t halt the disease, but it has been shown to slow cognitive and functional decline.

The debates over such drugs have been particularly fraught, since there is no cure for the affliction affecting more than 6 million Americans. Advocates have urged treatments for the memory-robbing disease that levies a harsh toll on families, but the medications have been dogged by complications such as bleeding in the brain.

Kisunla, which is the brand name for donanemab, slowed the cognitive and functional decline of patients with mild cognitive impairment by 35 percent over 18 months, a clinical trial found. The drug works by clearing a sticky plaque in the brain called amyloid beta, which is associated with the disease.

Kisunla is the third amyloid-targeting drug to win the FDA’s blessing since 2021, following two treatments – Aduhelm and Leqembi – jointly developed by drugmakers Eisai and Biogen.

The approval of Aduhelm deeply divided the medical community as critics argued there was not enough evidence to show the drug worked. The drugmakers stopped marketing Aduhelm after it fizzled commercially. But Leqembi received a warmer reception because later-stage data showed the treatment slowed cognitive and functional decline by 27 percent over 18 months, while Aduhelm had conflicting data.

Still, like the anti-amyloid drugs that came before it, donanemab has not been free of controversy. Three patients who received the drug in a clinical trial died of a complication from the drug. The condition, called ARIA, can cause the brain to swell or bleed. No such deaths occurred in the placebo group. Critics have also said that donanemab’s benefits, while statistically significant, are modest. Members of the advisory committee cautioned that the risks and benefits could vary depending on patients’ genetics and the stage of their disease.

The FDA in briefing documents last month had signaled that it was not overly alarmed by the drug’s safety profile, writing that the findings “are generally consistent” with the class of drugs that aim to reduce or eliminate amyloid plaques.

Though far from a cure, the recent Alzheimer’s drugs have kindled excitement among some researchers and advocates because of the potential to modify the course of the disease – effectively buying more time for those who suffer from it.

The drug is administered by infusion once a month. A key feature of Eli Lilly’s approach is that treatment with the drug could be discontinued once a patient’s amyloid levels are reduced to a certain level. That could reduce the burden on patients, but it remains unclear how testing for amyloid should be conducted.

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