Expectations rise for Lilly’s Alzheimer drug

Plans to submit the application to FDA in Q1 next year

Demonstrated reduced amyloid plaque in early-stage patients

Expectations have been rising for the commercialization of Lilly’s new drug candidate for Alzheimer’s.

 

On the 15th (local time), Eli Lilly announced that it will complete filing for approval of its new Alzheimer’s candidate ‘donanemab’ within the first quarter of 2022.

 

The news was announced at an investor meeting while introducing plans for five new drugs that will be launched within the next two years.

 

Lilly had previously said that an application for approval of donanemab would be made sometime next year.

 

if Lilly’s donanemab is approved, the addition of donanemab to the market following Biogen’s accelerated approval of Aduhelm in June is expected to intensify competition.

 

Although the information available on donanemab is limited, a head-to-head study against Aduhelm is ongoing, and initial data from the study is expected to roll out in the second half of next year.

 

Based on the initial data from a Phase II trial announced earlier this year, the FDA granted Breakthrough Therapy designation for donanemab in June.

 

Results of Lilly’s Phase II TRAILBLAZER-ALZ trial on donanemab is a monoclonal antibody that targets a modified form of beta-amyloid called N3pG that was released in July demonstrated that the reduced beta-amyloid deposits slowed the decline of cognitive function in Alzheimer patients.

 

Donanemab Patients with early symptoms of Alzheimer’s who were administered donanemab in the trial showed a rapid reduction in amyloid plaque at 24 weeks and showed the most rapid amyloid plaque removal in patients who had the most severe plaque burden at baseline.

 

At the meeting, Lilly also announced its release plans for its antidiabetic tirzepatide, mantle cell lymphoma treatment pirtobrutinib, ulcerative colitis treatment mirikizumab, and atopic dermatitis treatment lebrikizumab.