Eli Lilly’s amyloid-targeting Alzheimer’s disease (AD) drug has been unanimously endorsed by a US Food and Drug Administration (FDA) panel of experts.
The Peripheral and Central Nervous System Drug Advisory Committee voted 11 to zero that the benefits of donanemab outweighed its risks and that trial data submitted by Lilly showed the drug was effective.
The company is seeking approval of donanemab, administered intravenously, to treat AD patients who are presenting with mild cognitive impairment or mild dementia and have confirmed amyloid pathology.
Affecting approximately 6.9 million people in the US, AD is a progressive and ultimately fatal neurodegenerative condition that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Recent clinical studies have suggested that effective removal of toxic amyloid plaques in the brain can slow the cognitive deterioration of the disease.
Eisai/Biogen’s Leqembi (lecanemab), another amyloid-targeting treatment, is already approved in the US for patients with mild cognitive impairment or early-stage Alzheimer’s.
However, the FDA outlined that one available therapy is “not sufficient” and that “patients, caregivers and providers deserve multiple disease-modifying options”.
“Donanemab offers meaningful clinical benefit with a potential to stop treatment when treatment-related amyloid clearance is achieved and provides an additional and clinically important disease-modifying treatment for Alzheimer’s patients,” it said.
Lilly’s application was supported by results from mid- and late-stage trials, which demonstrated evidence of efficacy and clinically meaningful slowing of disease progression in patients treated with donanemab.
The efficacy results were consistent across trials, populations and endpoints, with greater relative benefit for those treated earlier in their course of disease.
The vote comes just one month after Eisai initiated a rolling Biologics License Application to the FDA for a subcutaneous version of Leqembi.
If approved, the autoinjector could be used to administer the drug at home or at medical facilities, with the injection process requiring less time than the currently-approved intravenous formulation.
Biogen also previously received FDA approval for its Alzheimer’s treatment, Aduhelm (aducanumab-avwa), but recently announced that it would be discontinuing the drug in favour of Leqembi and potential new treatment modalities.