FDA approves Alzheimer’s drug donanemab after months of delay

The Food and Drug Administration gave approval Tuesday to a closely watched Alzheimer’s drug, concluding that the benefits of modestly slowing the 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 to further review its safety and effectiveness. Last month, a panel of independent experts unanimously approved the drug, setting the stage for FDA sign-off.

Eli Lilly’s drug – Kisunla, the brand name for donanemab – is one of the few Alzheimer’s treatments being developed that modifies the underlying disease and will join only one other drug, Leqembi, on the commercial market. Kisunla – which was approved to treat early symptomatic Alzheimer’s disease – does not stop the disease but has been shown to slow cognitive and functional decline.

“I think it’s probably the highlight of the year for us,” said Daniel Skovronsky, Eli Lilly’s chief scientific officer, noting that there are “few diseases that are as scary with as few treatment options” as Alzheimer’s. . He said Kisunla will be available to patients in the coming weeks.

The debate over such drugs has been especially fierce because there is no cure for the condition that affects more than 6 million Americans. Advocates have pushed for treatments for the memory-robbing disease that takes a heavy toll on families, but medications have been stymied by complications such as bleeding on the brain.

Kisunla slowed cognitive and functional decline in 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 beta amyloid, which is linked to the disease.

Eli Lilly is pursuing an even bolder ambition: conducting trials to see if the drug can prevent Alzheimer’s by clearing amyloid in patients who don’t yet show symptoms.

The total cost of Kisunla will vary per patient depending on when they complete treatment. That’s because once a scan shows a patient has minimal levels of amyloid, they can stop treatment.

The estimated cost for a six-month course of therapy is $12,522. A full year of treatment is expected to cost $32,000, according to the drugmaker. However, many people probably won’t pay partial full list price since Medicare is expected to cover treatment for certain patients.

For some, the price may be higher than Leqembi’s estimated cost of $26,500 per year, although that treatment doesn’t stop after the amyloid is cleared.

Kisunla is the third amyloid-targeting drug to win FDA approval as of 2021, following two treatments — Aduhelm and Leqembi — jointly developed by drugmakers Eisai and Biogen.

Aduhelm’s approval deeply divided the medical community, as critics argued that there it was not enough evidence to show that the drug worked. Drugmakers stopped marketing Aduhelm after it exploded commercially. But Leqembi has 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.

However, 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 from a complication of the drug. The condition, called ARIA, can cause the brain to swell or bleed. There were no such deaths in the placebo group.

Critics have also said that the benefits of donanemab, although statistically significant, are modest. Advisory committee members cautioned that the risks and benefits may vary depending on patients’ genetics and the stage of their disease.

In briefing papers last month, the FDA signaled it was not overly alarmed by the drug’s safety profile, writing that the findings were “generally consistent” with the class of drugs aimed at reducing or eliminating amyloid plaques.

Although far from a cure, the latest Alzheimer’s drugs have sparked excitement among some researchers and advocates because of the potential to modify the course of the disease — effectively buying more time for those suffering from it.

“Having multiple treatment options is the kind of progress we’ve all been waiting for — all of us who are affected, even blind, by this difficult and devastating disease,” Joanne Pike, head of the Alzheimer’s Association, said in a statement. . .

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

The approval is unlikely to provide a meaningful boost to Lilly’s earnings in the near term. The Indianapolis-based firm has a stock market value of nearly $820 billion — the eighth-highest among publicly traded U.S. companies, and the highest among all pharmaceutical firms, according to S&P Global Market Intelligence. The company’s share price surge has been driven largely by the rapid success of its diabetes and weight loss drugs, namely Mounjaro and Zepbound.

Still, the approval marks a significant success for Lilly and could boost the prospects of other drugs that target amyloid, according to Wall Street analysts.

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