Btobioinnovation.com 

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #23.2

US FDA approves Lecanemab for the treatment of Alzheimer’s disease.

On January 6, the US FDA approved Eisai’s lecanemab, a beta amyloid antibody, via the Accelerated Approval pathway, for use in patients with mild cognitive impairment from Alzheimer’s disease, who have presence of amyloid beta pathology confirmed by positron emission tomography (PET). The approval is based on the 1,795 subject CLARITY AD study published in November 2022.

“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s instead of only treating the symptoms of the disease” said Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research (CDER).

The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations.

The drug will be sold by Eisai and Biogen under the name of Lequembi and priced at $26,500 per year according to an Eisai US official. The price is slightly lower than the one of Adulhelm, approved in 2021, but higher than recommended by ICER, a US price watchdog, who said in December that the drug would be cost effective at $8,500 to $20,600 per year.

In 2022, the Center for Medicare & Medicaid Services (CMS) has restricted the use of beta amyloid antibodies to patients in clinical trials and CMS said it would not reconsider its position until lecanemab gets a full approval, which could come later in the year. Eisai’s plan is “to file a full approval application within days” said Ivan Cheung Eisai’s US CEO. “It is not a cure, but I think any disease, like oncology, HIV and all these areas, you always need that initial, foundational spark. I think this could be that moment” said Cheung.

The drug is administered intravenously every two weeks in doses of 10 mg/kg. The FDA prescribing information for Lequembi includes a warning for amyloid-related imaging abnormalities (ARIA) which occur with beta amyloid antibodies. ARIA usually does not have symptoms although serious and life-threatening events may occur. Another warning for Lequembi is for a risk of infusion-related reactions such as flu symptoms, nausea, vomiting, changes in blood pressure and headache. In the label, FDA notes MRI monitoring for ARIA should be done prior to treatment and again before the fifth, seventh and 14^th infusions. The label includes no boxed warnings, no risk evaluation and mitigation strategy (REMS) and no contraindications.

Eli Lilly’s donanemab, another beta amyloid antibody, is currently under FDA review and is expecting an accelerated approval in February. Lilly should have final results from a 1,800 patient trial in April.

We will publish a comprehensive commentary on this topic in the February issue of MedNous.

Paris, January 7, 2022.

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