Eisai Co.’s new global Alzheimer’s officer Keisuke Naito is shifting the focus of the program to winning regulatory clearance of its groundbreaking medicine Leqembi in other markets after gaining US approval.
(Bloomberg) — Eisai Co.’s new global Alzheimer’s officer Keisuke Naito is shifting the focus of the program to winning regulatory clearance of its groundbreaking medicine Leqembi in other markets after gaining US approval.
“The hurdles of winning US approval was really high and it was the main stage until now,” Naito said in a post-earnings briefing held in Tokyo Wednesday, adding that the program will now be run out of the drumaker’s home country of Japan. “As we move on to commercialization there, other regions such as Japan, China and Europe are going through similar phases.”
Keisuke Naito officially took over the job this month, after predecessor Ivan Cheung, who was based in the US, retired after leading the push for US approval of the treatment for Alzheimer’s disease.
Both Naito, 34, and Cheung are members of the Japanese pharmaceutical giant’s founding family. Keisuke Naito is the son of chief executive officer Haruo Naito, while Cheung is his son-in-law. The change in leadership was announced less than a week after Eisai and partner Biogen Inc. were granted full approval for Leqembi in the in the US. It’s the first medicine shown to slow progression of Alzheimer’s, which afflicts some 6 million Americans.
Eisai is currently seeking approval for the drug in other markets, including Japan. It will be reviewed by a panel of advisers to Japan’s health ministry on Aug. 21, according to local media.
Despite the restrictions given to the drug by the US regulators last month, Eisai is making “a good progress” for Leqembi to be used by 10,000 patients in the US by March 2024, Naito said.
Leqembi gained full approval in the US last month, a move that’s expected to spur greater insurance coverage for the drug, which costs $26,500 a year. Still, unexpected restrictions have arisen that may limit its use and sent Eisai’s shares sliding. They include a requirement for MRI scans in order to monitor early signs of side effects, and a label on the drug that includes the strictest warning about the danger of swelling and bleeding in the brain.
Doctors must also closely monitor patients and detail their response in a Centers for Medicare & Medicaid Services registry every six months for the first two years of use. Eisai said the warning would apply to the entire class of drugs to which Leqembi belongs, and that it was intended to raise awareness about side effects.
Keisuke Naito was previously in charge of strategy planning and helping to create a platform collecting data and coming up with solutions to detect dementia early. He joined Eisai in 2013 and became an executive officer in 2019, before being named a senior vice president in June.
Naito has “enjoyed a rapid rise through the ranks since joining Eisai,” Jefferies Japan Ltd. analyst Stephen Barker said when he was appointed Alzheimer’s head last month. “This is a very heavy responsibility for a relatively young executive with limited commercial experience in sales and marketing roles.”
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