BioArctic, Eisai seek re-examination of CHMP’s negative opinion on Alzheimer’s drug

UK—BioArctic AB’s partner Eisai has announced their intention to request a re-examination of the Committee for Medicinal Products for Human Use’s (CHMP) negative opinion on the Marketing Authorization Approval (MAA) for lecanemab, a treatment for Alzheimer’s disease, in the European Union.

According to Reuters, this opinion has significantly impacted the market, with shares of Japan’s Eisai dipping by 11%, marking one of the biggest single-day declines in three years.

The EU drugs regulator cited concerns that the risk of serious brain swelling associated with lecanemab did not outweigh its modest effect on slowing cognitive decline.

In response to this decision, both Eisai and BioArctic have emphasized their plan to seek a re-examination of the recommendation. However, they have not disclosed the specific information they plan to present to the regulator.

Under the formal re-examination request process, the applicant is allowed 60 days to present the CHMP with the grounds for the re-examination.

Subsequently, the CHMP, led by new rapporteurs, will have an additional 60 days to respond. This process allows for a thorough review and consideration of any new evidence or arguments presented by the applicant.

Lecanemab has already received approval in several countries, including the United States, Japan, China, South Korea, Hong Kong, and Israel.

It is currently being marketed in the U.S., Japan, and China, demonstrating its global reach and the potential impact it could have on patients with early Alzheimer’s disease.

Gunilla Osswald, CEO of BioArctic, expressed surprise and disappointment at the CHMP’s opinion.

She described the negative opinion as a setback for patients, caregivers, and healthcare professionals in the EU who now face a prolonged wait for a treatment that could alter the course of this devastating disease.

Osswald emphasized the importance of time for these patients, noting that denying them access to a treatment that delays the onset of more severe stages of Alzheimer’s is not the outcome they had hoped for.

She reiterated that this was not the final verdict and assured them that Eisai will continue to work with authorities to make this treatment available to eligible patients in the EU as soon as possible.

Alzheimer’s disease currently affects 6.9 million people in Europe, a number expected to double by 2050 due to aging populations.

Eisai is responsible for the clinical development, market approval applications, and commercialization of lecanemab for Alzheimer’s disease.

BioArctic holds the right to commercialize lecanemab in the Nordic region, pending European approval, and both companies are preparing for a joint commercialization effort in the region.

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