Eisai Co. 4523, -9.06% shares fell as much as 9.2% early Thursday morning after a Japanese government panel sought additional data for a review of the company’s Aduhelm drug for Alzheimer’s.
Biogen Inc. and Eisai, which co-developed the medication, said they remained committed to bringing Aduhelm to patients in Japan soon.
Aduhelm’s commercial potential has dropped significantly given recent regulatory developments in Europe and Japan, as well as criticism over its regulatory approval in the U.S., Nomura analyst Motoya Kohtani said in a report.
Earlier this month, the European Medicines Agency recommended not granting Aduhelm marketing authorization.
Biogen and Eisai said they will continue to engage with Japanese government officials on additional data requirements.
Eisai shares were 8.8% lower at 6,498 yen ($56.94) at the close of the morning session in Tokyo.