Biogen, Eisai’s lecanemab gets the Alzheimer’s nod, but how successful it will be uncertain

The US FDA on Friday issued accelerated approval of Biogen (NASDAQ:BIIB) and Eisai’s (OTCPK:ESALY) Leqembi (lecanemab), is only the second biologic drug ever approved for Alzheimer’s disease.

The therapy is expected to be available worldwide week of January 23. It comes with a wholesale cost of $26.5k per year based on twice-monthly infusions.

While the approval is great news, it remains to be seen whether Leqembi will become the revenue home ground. After all, the two companies won Aduhelm (aducanumab) approval in 2021 hoping it would turn out to be a blockbuster, only to be hit back by criticism for its mediocre performance and April 2022 CMS National Coverage Determination (NCD) cover the drug only in very rare cases.

Indeed, the NCD for Leqembi – which has yet to be rendered – will be critical to its success since the vast majority of those eligible for the treatment are Medicare enrollees.

Furthermore, at the time of Aduhelm NCD, CMS said that FDA-approved monoclonal antibodies that target amyloid – a protein in the brain thought to contribute to Alzheimer’s disease – would Covered only during a clinical trial conducted with regulatory authorization. For CMS to embrace Leqembi, it needs to adjust this stance.

Full approval for Lequembi can help CMS make decisions about protecting Lequembi. Esai (OTCPK:ESALF) on Friday said it will promptly submit a Supplemental Biology Licensing Application with data from the Clarity AD Phase 3 trial to do so.

Another potential concern is label for Leqembi. The indicated patient population is much narrower than that of Aduhelm. As for Leqembi, it “should be started” in people with mild cognitive impairment and mild dementia stages of Alzheimer’s disease.

Of course, doctors are free to prescribe Leqembi to anyone who shows signs of Alzheimer’s disease regardless of stage. However, a narrower population of prescribing information will likely affect many health professionals.

Another concern for doctors considering prescribing Leqembi is the treatment’s safety profile. The label contains a warning to watch for Amyloid-Associated Imaging Abnormalities (“ARIA”) – characterized by swelling and bleeding in the brain – during the first 14 weeks of treatment.

ARIA has been seen in some patients in clinical trials. In addition, in December, lecanemab was associated with the death of a third patient in a trial.

Jason Karlawish, co-director, Penn Memory Center, Perelman School of Medicine, University of Pennsylvania, says the presence of the APOE4 gene can not only predict a person’s risk of bleeding in the brain, but also effectiveness levels. fruit of Leqembi. Possession of the gene is considered a genetic risk factor for Alzheimer’s disease.

Karlawish notes that data from the Leqembi trials indicate that people with the APOE4 gene have more bleeding in the brain and bleeding, and that the drug doesn’t work for them either.

“For individuals making the decision whether or not to take this drug, I believe, I think, many clinicians like myself feel that APOE4 testing needs to be one of the options to consider. whether this is the right drug for me – and what are my chances of benefit and risk,” he said.

Wall Street looks bullish on Leqembi’s prospects with some analysts expressing confidence on Friday that it will hit a positive NCD.

However, Piper Sandler’s Christoper Raymond is not among them. Raymond, who has a neutral review of Biogen (BIIB), said he was concerned about Leqembi’s commercial success amid uncertainty about doctor admissions and the hassle of biweekly infusions.