- Eli Lilly is pushing back the timing for when it expects to finish submitting an application for U.S. approval of its experimental drug for Alzheimer's disease, revealing Thursday it now will complete the filing to the Food and Drug Administration by the end of the year, rather than by the end of March.
- The delay for Lilly's treatment, called donanemab, follows a draft decision by Medicare to sharply limit coverage of Biogen's new Alzheimer's drug Aduhelm and other medicines like it. Aduhelm won an accelerated approval last June, but its clearance was controversial.
- As a result of Medicare's policy, Lilly is placing less emphasis on its plan to seek accelerated approval for donanemab, which is supported by results from a small trial, and focusing instead on an ongoing larger study that measures patient outcomes. "I don't think investors should look at [accelerated approval] as a big commercial inflection point," said Daniel Skovronsky, Lilly's chief medical officer, on a conference call Thursday.
Lilly's announcement is a consequence of Medicare's draft policy, which, if finalized later this year, would restrict coverage for Aduhelm and donanemab to people enrolled in randomized, placebo-controlled trials.
Both drugs work by targeting deposits of a sticky protein, called amyloid beta, in the brain. Amyloid buildup has long been believed to cause Alzheimer's, although nearly every trial of an amyloid-targeting drug has failed to slow disease progression. One of the main trials testing Aduhelm, for instance, showed no benefit to the drug, a result that's fueled debate over how well the drug actually works.
The FDA, however, granted Aduhelm accelerated approval based on data showing it can clear amyloid, a surprise decision that led Lilly to revise its plans and seek the same for donanemab based on similar data. While that plan hasn't changed, it's become less urgent because of Medicare's policy.
"We're trying to take investor focus off the exact timing of accelerated approval, given our very limited expectations for the impact of that accelerated approval commercially," Skovronsky said during Lilly's fourth quarter 2021 earnings call. "We're still pursuing it. We think there's some opportunity to help patients."
Lilly's submission is one of at least two Alzheimer's drugs the FDA will review this year. On Thursday, Biogen said its development partner Eisai will submit a second amyloid-blocking drug called lecanemab to the FDA between April and June.
On their call, Lilly executives also raised concerns that Medicare's decision could block coverage even for those drugs that show they can delay Alzheimer's progression, as donanemab did in its Phase 2 trial.
They plan to clarify the policy with the Centers for Medicare and Medicaid Services, or CMS, and are seeking broader coverage for drugs with positive Phase 3 results.
"What we believe is that with Phase 3 confirmatory data and ultimately an FDA traditional approval, we cannot envision a reason why CMS would treat Alzheimer's disease differently than any other class of medicines," said Anne White, president of Lilly's neuroscience division. "This would really be unprecedented and I believe the pushback from the patient community, from their caregivers and from those that advocate for them would be significant."