USA – Eli Lilly has pushed back the deadline for submitting an application for U.S. approval of its experimental Alzheimer’s disease drug, revealing that it will now complete the filing to the Food and Drug Administration by the end of the year, rather than the end of March.
The postponement of Lilly’s treatment, known as Donanemab, follows a draft decision by Medicare to severely limit coverage of Biogen’s new Alzheimer’s drug Aduhelm and other similar medications.
Aduhelm received accelerated approval in June, but its approval was contentious.
As a result of Medicare’s policy, Lilly is focusing less on its plan to seek accelerated approval for Donanemab, which is based on the results of a small trial, and more on an ongoing larger study that measures patient outcomes.
Lilly’s announcement is a result of Medicare’s draft policy, which, if finalized later this year, would limit coverage for Aduhelm and Donanemab to participants in randomized, placebo-controlled trials.
Both drugs work by preventing the buildup of a sticky protein in the brain known as amyloid beta Amyloid buildup has long been thought to cause Alzheimer’s disease, but nearly every amyloid-targeting drug trial has failed to slow disease progression.
“I don’t think investors should look at [accelerated approval] as a big commercial inflection point.”
One of the main trials testing Aduhelm, for example, found no benefit to the drug, fueling debate about how well the drug actually works.
The FDA, on the other hand, granted Aduhelm accelerated approval based on data demonstrating that it can clear amyloid, a surprising decision that prompted Lilly to revise its plans and seek accelerated approval for Donanemab based on similar data.
While that plan hasn’t changed, the policy of Medicare has made it less urgent.
The FDA will review at least two Alzheimer’s drugs this year, according to Lilly’s submission. Biogen and its development partner Eisai have announced that they will submit a second amyloid-blocking drug called Lecanemab to the FDA between April and June.
On the call, Lilly executives expressed concern that Medicare’s decision could prevent coverage even for drugs that have shown to delay Alzheimer’s progression, such as Donanemab in its Phase 2 trial.
They intend to clarify the policy with the Centers for Medicare and Medicaid Services, or CMS, and to seek broader coverage for drugs that have achieved positive Phase 3 results.
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