Eisai learns from Biogen’s Aduhelm disaster

Leqembi's accelerated approval sees Eisai upholding its part of the bargain, setting a reasonable price and moving fast with confirmatory data.

Where Biogen brought chaos and controversy Eisai is proceeding with calm confidence. Friday’s US approval of lecanemab, for which Eisai is wholly responsible, brought no unpleasant surprises, and a price well below that of Biogen’s Aduhelm puts the Japan group in a relatively strong position to get a positive reimbursement decision.

What will surprise some is that the FDA gave lecanemab, now trademarked Leqembi, accelerated approval on the day of its Pdufa date – without waiting to review confirmatory randomised data – and that within a day Eisai had submitted those data, seeking to secure a full green light. The signs are that Eisai is doing everything possible to avoid the controversy Biogen had courted when Aduhelm was approved in mid-2021.

In the wake of Aduhelm’s approval, which led to the CMS effectively refusing to reimburse the drug, and ultimately saw off Biogen’s head of R&D and chief executive, the companies’ long-standing Alzheimer’s deal was renegotiated. Operational control over Aduhelm was given to Biogen, and Eisai doubled down on lecanemab.

Some analysts had suggested that Eisai had taken back control to such an extent that Biogen was not even allowed to see full data from lecanemab’s Clarity-AD trial before these were presented at CTAD. In a short statement on Leqembi’s approval on Friday Biogen commended Eisai, pointed investors to Eisai’s own release and said the Japan group was solely responsible for pricing.

Lower than Aduhelm

That pricing has come in at $26,500 a year. Notably this is lower even than the $28,200 to which Biogen had slashed Aduhelm in the face of opposition to its initial cost of $56,000 a year.

Nevertheless, according to Evercore ISI analysts Leqembi’s cost is slightly above investor expectations, which they put at $20,000-25,000. The US watchdog Icer suggested $8,500-20,500 as an acceptable price; clearly a positive CMS decision is far from assured.

The Leqembi label does not restrict the drug’s use in ApoE4-positive patients, and suggests when dosing should be suspended in the event of Aria-E occurrence. Importantly, Leqembi is indicated for mild disease, “the population in which treatment was initiated in clinical trials”; part of Aduhelm’s problem was that the FDA had approved it broadly for Alzheimer’s, arguably resulting in the CMS’s reimbursement crackdown.

For now Leqembi is approved solely on the basis of biomarkers and plaque clearance in a dose-finding study. One concern had been that the FDA would refuse to approve lecanemab on an accelerated basis at its Pdufa date, instead delaying a decision so it could review the positive results of Clarity-AD.

Eisai had initially suggested that it would submit the Clarity-AD data by March, so the fact it managed to do so on Saturday shows just how keen it is not to leave the accelerated approval hanging. Should full approval now follow, which on the strength of Clarity-AD looks likely, attention will turn to whether and on what grounds the CMS decides to reimburse Leqembi.

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