Biogen was granted an expedited approval by the US FDA Friday (NASDAQ:BIIB) and Eisai’s (OTCPK:ESALY Leqembi (lecanemab) is the second approved biologic medicine for Alzheimer’s disease.
The therapy is expected be available by the end of this year. Week of January 23. It has a wholesale price of $26.5K annually, based on two monthly infusions.
While the approval is great news, it remains uncertain whether Leqembi can make a significant revenue increase. The approval of Aduhelm (aducanumab), which was approved by the two companies in 2021, was expected to make it a huge success. However, they were met with criticisms of its efficacy and an April 2022 CMS National Coverage Determination to cover that medication only in rare cases.
As the majority of Medicare patients are eligible, it will be crucial that the NCD for Leqembi is rendered.
CMS also stated that FDA-approved monoclonal antibodies that target amyloid (the protein that is thought to cause Alzheimer’s) will not be covered by clinical trials without regulatory authorization. CMS will need to modify its position in order to be able to cover Leqembi.
CMS could benefit from Leqembi’s full approval in order to make a decision about whether or not it will cover the drug. Eisai (OTCPK.ESALF) stated Friday that it will quickly file a Supplemental Biologics License Application containing data from the phase 3 Clarity AD trial.
Another concern is the labeling for Leqembi. It is not indicated for patients with Aduhelm. Leqembi says it should be started in patients with mild cognitive impairment or mild dementia.
No matter the stage, Leqembi can be prescribed by doctors to any person with Alzheimer’s. The prescribing information for a smaller population will likely impact many medical professionals.
The safety record of Leqembi treatment is another concern for doctors who are considering prescribing it. The labeling includes a warning that doctors should monitor for Amyloid Related Imaging Anormalities (“ARIA”) during the first 14 weeks. ARIA is characterized as brain swelling or bleeding.
Some patients with ARIA were seen during clinical trials. A third patient died in December after lecanemab had been administered to them.
Jason Karlawish is the co-director of Penn Memory Center, Perelman Medical School, University of Pennsylvania. He said that one’s risk of developing brain bleeding by having the APOE4 gene can be predicted, and Leqembi could also work well. This gene is a genetic risk factor to Alzheimer’s.
Karlawish pointed out that Leqembi trials data showed that people with the APOE4 genes had more brain bleeds, and they were less effective than those without the gene.
“For individuals making the decision whether 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 the right drug for me — and what are the chances of me benefitting as well as suffering risks,” he said.
Wall Street seems bullish about Leqembi’s prospects, with many analysts declaring confidence that the company will achieve a positive NCD on Friday.
Piper Sandler’s Christoper Raymond wasn’t. Raymond, who holds a neutral rating for Biogen (BIIB), expressed concern about Leqembi’s commercial success in the face of uncertainty over doctor uptake as well as the inconvenience of having to have infusions every other week.