The company announced yesterday that a November meeting on its Marketing Authorization Application for aducanumab with the Committee for Medicinal Products for Human Use (CHMP) resulted in a negative trend vote from the committee, although it did not provide any further details.
The CHMP's job is to carry out scientific assessments of applications and recommend whether the medicine should be marketed or not. As part of the process, it may invite an applicant to provide oral explanations, then inform the applicant of the trend at CHMP level ahead of any formal vote.
“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen.
The monoclonal antibody was approved by the US FDA as Aduhelm in June, making it the first therapy to target and affect the underlying disease process of Alzheimer’s (as opposed to simply treating symptoms of the disease like previous therapies). However, the approval has not been without controversy, and the FDA’s accelerated approval requires a new randomized controlled Phase 4 clinical trial to verify the drug’s clinical benefit.
In the EU, the EMA accepted Biogen's Marketing Authorization Application for aducanumab in October last year. The application is for aducanumab 100 mg/mL concentrate solution for infusion for the treatment of Alzheimer’s disease. The CHMP is expected to adopt a formal opinion on the application at its December meeting (December 13-16, 2021).
The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of Aduhelm in the US was granted based on data from clinical trials showing the effect of Aduhelm on reducing amyloid beta plaques.
Biogen last week announced new Phase 3 data that 'provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease.'