Eisai says early Leqembi rollout exceeds its hopes

Eisai didn't reveal sales of its new Alzheimer's disease therapy Leqembi in its third-quarter update, but said the launch was running "ahead of expectations" since the drug arrived in US pharmacies in the middle of last month.

The first sales of the $26,500-per-year amyloid-targeted drug were recorded on 18th January – just days after the accelerated approval – with the first prescriptions for Leqembi (lecanemab) written on 23rd January and the first patient infusion taking place last Friday.

It is early days, of course, but encouraging signs for Eisai and partner Biogen given the abortive launch of Leqembi's predecessor Aduhelm (aducanumab) last year.

Eisai US chief executive, Ivan Cheung, said on a call with investors that interest in Leqembi from doctors, health systems, and payers was running high, with "many requests" for the drug coming in that bode well for its prospects – if access challenges can be overcome.

Any dosing of Leqembi to date will be in patients paying out of pocket for the drug or those enrolled in Eisai's patient assistance programme, which provides it at no cost to eligible uninsured and underinsured patients.

Material sales will depend on the Centers for Medicare & Medicaid Services (CMS) relaxing its policy of limiting coverage of amyloid drugs to patients in clinical trials, introduced as a result of the controversy surrounding the approval and launch of Aduhelm.

In its update, Eisai said that communication with CMS is "steadily ongoing" and that it is hoping for "broad and simple coverage to label" if the current accelerated approval is upgraded to a full approval later this year.

Last month, CMS said it "is examining available information and may reconsider its current coverage" based on a review of the data on lecanemab, and confirmed that the drug would not be subject to the same restrictions if it goes on to secure full approval.

Eisai also said it had completed a programme of presenting the results of the Clarity AD trial that supported approval of Leqembi to major payers in the US, and that several of these are in advanced discussions about including the drug on their formularies.

The company maintains that Leqembi's wholesale acquisition cost of $26,500 delivers a projected societal value of $37,600 and that over 10 years "could bring potential positive social impact of several tens of billion dollars to US society."

It is also hoping for approval of the drug in Japan in the middle of 2023, and in Europe and China before the end of the next fiscal year, ending 31st March 2024.