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Amsterdam – The European Medicines Agency (EMA) is forced to review its own negative vote on the new Alzheimer’s drug Lecanemab.

“The Committee for Medicinal Products for Human Use (CHMP) of the EMA recently began re-examining the marketing authorization application for lecanemab at the request of the applicant,” the EMA said in response to a request from German medical journal with.

At the end of July, the CHMP recommended that the EU Commission not approve the Alzheimer’s drug (trade name Leqembi), which targets the protein amyloid-beta, because “the observed effect of Leqembi on delaying cognitive decline does not outweigh the risk of serious side effects “, as it was said in an EMA statement at the time.

Lecanemab would be the first Alzheimer’s drug in this country to combat the cause of the disease. In Germany, the vote at the end of July triggered very different reactions.

For example, the German Alzheimer Society saw a “responsible decision in the interests of the patients”. The President of the German Society for Psychiatry and Psychotherapy, Psychosomatics and Neurology (DGPPN), however, spoke of a “significant disadvantage for sufferers in the EU”.

The Leqembi manufacturer, the Japanese pharmaceutical company Eisai, announced shortly after the EMA decision that it would apply for a new examination.

Lecanemab has been available in the USA since the beginning of 2023. Although the therapy does not improve the symptoms, it can slow down the progression of the disease somewhat in the early stages. The antibody would only be suitable for a very limited group of Alzheimer’s patients

The EMA declined to comment on when the review might be completed. “Unfortunately, as long as the evaluation of a drug has not yet been completed, we cannot provide any information about the expected timelines or possible results.”

For the so-called re-examination, the EMA must appoint two new rapporteurs. In total, the CHMP has a time window of 60 days, with possible interruptions, to reach a final result.

The review “will examine only the points raised by the applicant in the statement of grounds of appeal and will be based only on the scientific data available at the time the Committee adopted the original opinion.” This means that Eisai will not add any new data to its can present medication.

The EMA also has an application for another Alzheimer’s antibody. This is about the drug Donanemab from the manufacturer Eli Lilly (trade name Kisunla). The testing process is currently paused so that the manufacturer can respond to questions from the CHMP. © fri/aerzteblatt.de