Lilly Delays Alzheimer’s BLA Due to Aduhelm Debacle
Eli Lilly is delaying a planned BLA accelerated approval submission for its Alzheimer’s investigational antibody therapy donanemab due to uncertainties related to a Center for Medicare and Medicaid Services (CMS) decision (see earlier story) to propose restricting Medicare coverage of Biogen’s Alzheimer’s drug Aduhelm (aducanumab). Lilly was planning a first quarter submission and that is now being pushed back to much later this year as the company awaits additional Phase 3 confirmatory data to support a traditional approval and sidestep the recent controversial CMS decision altogether. The decision essentially says that coverage would be limited to use in randomized controlled trials under conditions approved by CMS.
On a 2/3 earnings call, the company said it has had low expectations on the use of donanemab during the period between potential accelerated approval and the availability of confirmatory Phase 3 data in mid-2023. “While the accelerated approval pathway was instituted by the FDA to allow for earlier approval of drugs to treat serious conditions and fill an unmet medical need and is providing valuable access to more patients faster than what is available under clinical trials, the [coverage decision] as currently written essentially negates that patient benefit in Alzheimer’s disease,” Lilly senior vice president and chief scientific and medical officer Daniel M. Skovronsky told financial analysts on the call.
Lilly Neuroscience president Anne White elaborated further on the call, saying that the company does not believe that the final coverage decision, which is due in April, may not change very much. “Really what matters most to us is ensuring rapid availability of donanemab for patients with the confirmatory Phase 3 data,” she said. “And so that’s going to be our focus with CMS. We believe that well-designed and controlled registration trials like TRAILBLAZER ALZ and ALZ 2 should certainly provide sufficient evidence of clinical benefit for donanemab. And that the [coverage decision] is not needed or appropriate for donanemab.”
White said she believes the industry is going to see confirmation from CMS “that once this Phase 3 efficacy and safety has been established, that donanemab and other medicines with this level of verified evidence would be fully covered by CMS. And we want that path for this coverage to be clearly laid out... (W)hat 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. I mean, 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 and CMS will have, we believe, no choice but to change it. So our focus is on that Phase 3 data.”