an advisory panel to the japanese drug regulator is continuing deliberations on the new drug application filed by biogen inc biib and partner eisai co ltd esaly 4523  the companies said wednesday the ndc new drugs committee is seeking additional data to be submitted as part of this process said the statement the companies will continue to actively engage with the pharmaceuticals and medical devices agency pmda in japan to agree on additional data requirements biogen and eisai remain committed to bringing aducanumab to patients in japan expeditiously aduhelm was granted approval in the us by the food and drug administration last june but has been mired in controversy over that decision ever since in july biogen asked for a narrower indication several members of the fdas advisory committee who had voted against the agencys approving aduhelm quit in response and acting fda commissioner janet woodcock in july announced a federal investigation into the process behind the aduhelm approval earlier this week biogen said it will halve the price of the treatment in january after it failed to gain traction in the us biogen shares were slightly lower premarket and have fallen 4 in 2021 while the sp 500 spx has gained 24