FDA sets June adcomm date for Lilly’s Alzheimer’s drug

The FDA has confirmed that it will convene an advisory committee meeting on 10th June to discuss Eli Lilly’s Alzheimer’s disease candidate donanemab, after announcing a delay to its review earlier this year.

The keenly anticipated meeting of the Peripheral and Central Nervous System Drugs (PCNS) panel will cover Lilly’s application to market donanemab as a treatment for early symptomatic Alzheimer’s, which is vying to join Eisai and Biogen’s Leqembi (lecanemab) as the first disease-modifying therapies for the disease.

The FDA had been scheduled to deliver a decision on the application before the end of March – after a three-month delay – but decided to call for an adcomm a couple of weeks before that was due, prompting speculation about the chances of approval.

Now, all eyes will be on the reviewers’ briefing document that will be published in the build-up to the meeting to get an idea of the FDA’s stance on the drug.

Lilly had previously sought early accelerated approval of donanemab from the FDA – which was granted to Leqembi – but that route was blocked off by the regulator, which had questions about the design of Lilly’s pivotal TRAILBLAZER-ALZ 2 study and wanted to see the full dataset.

The results were published last year and showed a 35% reduction compared to placebo on the Integrated Alzheimer’s Disease Rating Scale (iADRS) measure of cognitive function after 18 months, along with a 36% improvement over control on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) measure.

Around a quarter (24%) of patients had amyloid-related imaging abnormalities (ARIA) – a recognised side effect with amyloid drugs, which can have serious consequences – with serious cases seen in 1.6% of patients taking the drug, including three deaths – and that will also be a point of discussion in the adcomm meeting.

Lykos’ MDMA-based drug also up for scrutiny

Before donanemab takes the stand, on 4th June another group of FDA advisors will also cast their eye over Lykos Therapeutics’ psychedelic medicine for the treatment of post-traumatic stress disorder (PTSD) – midomafetamine capsules – which is based on Schedule 1 drug MDMA.

The meeting is seen as a big moment for the emerging field of psychedelic medicines, based on drugs more commonly associated with illicit recreational use, and will also be the first assessment of a new therapy for PTSD in 25 years.

One of the main issues affecting the class is the difficulty in designing studies with a blinded control group, given their obvious and overt effects on the brain.

Lykos’ chief executive, Amy Emerson, said midomafetamine will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC).

The advisors will review results from two phase 3 trials of the drug, MAPP1 and MAPP2, that have been published in the journal Nature Medicine. The FDA is due to deliver a decision on the drug by 11th August.