The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated that it has adopted a negative opinion on BioArctic AB’s partner Eisai’s Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer’s disease.
Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, and Israel and is being marketed in the U.S., Japan and China.
Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer’s disease. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
Eisai will seek re-examination of CHMP opinion
BioArctic’s partner Eisai announced hat they will request re-examination of the Committee for Medicinal Products for Human Use (CHMP’s) negative opinion posted on the Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer’s disease in the EU.
This is not the final verdict however, and our partner Eisai will seek re-examination of the CHMP opinion and continue work with authorities to ensure this treatment is available for eligible people living with early Alzheimer’s disease in the EU as soon as possible.”
“We are surprised and very disappointed by the CHMP’s opinion posted today. Foremost the negative opinion adopted by the CHMP is sad for all patients, caregivers and healthcare professionals in the EU who will now have to wait longer for a treatment which can effectively change the course of this devastating disease. We know that for these patients, time is what they value the most, and potentially denying them a treatment which has been shown to delay the onset of more severe stages of the diseases is of course not what they or we had hoped for,” says Gunilla Osswald, BioArctic’s CEO. “This is not the final verdict however, and our partner Eisai will seek re-examination of the CHMP opinion and continue work with authorities to ensure this treatment is available for eligible people living with early Alzheimer’s disease in the EU as soon as possible.”
Photo of Gunilla Osswald: BioArctic
