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CHMP issues positive recommendation for approval of lecanemab in the EU

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BioArctic AB announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for lecanemab as an Alzheimer's disease treatment in the EU. The recommendation applies to adult patients with early Alzheimer's who are apolipoprotein E ε4 heterozygotes or non-carriers. This follows a re-examination of CHMP's earlier negative recommendation, with European Commission's decision expected within 67 days. Lecanemab is already approved in multiple countries including the US, Japan, and China. BioArctic holds Nordic region commercialization rights, while partner Eisai handles development and commercialization elsewhere.

BioArctic AB annuncia che il Comitato per i Medicinali per Uso Umano (CHMP) dell'EMA ha emesso una raccomandazione positiva per il lecanemab come trattamento per l'Alzheimer nell'UE. La raccomandazione si applica a pazienti adulti con Alzheimer precoce che sono eterozigoti per l'apolipoproteina E ε4 o non portatori. Questo segue una riesamina della precedente raccomandazione negativa del CHMP, con la decisione della Commissione Europea prevista entro 67 giorni. Lecanemab è già approvato in diversi paesi, tra cui Stati Uniti, Giappone e Cina. BioArctic detiene i diritti di commercializzazione nella regione nordica, mentre il partner Eisai si occupa dello sviluppo e della commercializzazione altrove.

BioArctic AB anuncia que el Comité de Medicamentos para Uso Humano (CHMP) de la EMA ha emitido una recomendación positiva para el lecanemab como tratamiento para la enfermedad de Alzheimer en la UE. La recomendación se aplica a pacientes adultos con Alzheimer temprano que son heterocigotos para la apolipoproteína E ε4 o no portadores. Esto sigue a un reexamen de la anterior recomendación negativa del CHMP, y se espera que la decisión de la Comisión Europea se tome en un plazo de 67 días. Lecanemab ya está aprobado en varios países, incluidos EE. UU., Japón y China. BioArctic tiene los derechos de comercialización en la región nórdica, mientras que su socio Eisai maneja el desarrollo y la comercialización en otros lugares.

BioArctic AB는 EMA의 의약품 인간 사용을 위한 위원회(CHMP)가 알츠하이머 질환 치료제로서 레카네맙에 대해 긍정적인 권고를 발표했다고 알렸습니다. 이 권고는 아포리포 단백질 E ε4 이형접합체 또는 비보유자인 초기 알츠하이머 성인 환자에게 적용됩니다. 이는 CHMP의 이전 부정적 권고에 대한 재검토 후에 이루어진 것이며, 유럽연합 집행위원회의 결정은 67일 이내에 예상됩니다. 레카네맙은 이미 미국, 일본, 중국을 포함한 여러 국가에서 승인되었습니다. BioArctic은 북유럽 지역의 상업화 권리를 보유하고 있으며, 파트너인 Eisai는 다른 지역의 개발 및 상업화를 처리합니다.

BioArctic AB annonce que le Comité des Médicaments à usage humain (CHMP) de l'EMA a émis une recommandation positive pour le lecanemab en tant que traitement de la maladie d'Alzheimer dans l'UE. La recommandation s'applique aux patients adultes atteints d'Alzheimer précoce qui sont hétérozygotes pour l'apolipoprotéine E ε4 ou non porteurs. Cela fait suite à un réexamen de la précédente recommandation négative du CHMP, la décision de la Commission européenne étant attendue dans un délai de 67 jours. Lecanemab est déjà approuvé dans plusieurs pays, dont les États-Unis, le Japon et la Chine. BioArctic détient les droits de commercialisation dans la région nordique, tandis que son partenaire Eisai gère le développement et la commercialisation ailleurs.

BioArctic AB gibt bekannt, dass das Ausschuss für Humanarzneimittel (CHMP) der EMA eine positive Empfehlung für Lecanemab als Behandlung der Alzheimer-Krankheit in der EU ausgesprochen hat. Die Empfehlung gilt für erwachsene Patienten mit frühem Alzheimer, die Apolipoprotein E ε4-Heterozygoten oder Nichtträger sind. Dies folgt einer erneuten Prüfung der früheren negativen Empfehlung des CHMP, wobei eine Entscheidung der Europäischen Kommission innerhalb von 67 Tagen erwartet wird. Lecanemab ist bereits in mehreren Ländern, einschließlich der USA, Japan und China, zugelassen. BioArctic hält die Vermarktungsrechte für die nordische Region, während der Partner Eisai die Entwicklung und Vermarktung anderswo übernimmt.

Positive
  • CHMP reverses previous negative recommendation to positive for lecanemab approval in EU
  • Product already approved in major markets including US, Japan, and China
  • BioArctic holds valuable Nordic region commercialization rights
Negative
  • patient population (only ApoE ε4 heterozygotes or non-carriers)
  • Final EU approval still pending European Commission decision

Insights

The CHMP positive recommendation for lecanemab marks a significant milestone in Alzheimer's treatment in the EU. The approval scope targeting ApoE ε4 heterozygotes and non-carriers reflects a precision medicine approach, focusing on patients most likely to benefit with manageable risk profiles. This strategic positioning could optimize the risk-benefit ratio and treatment outcomes.

With approvals already secured in major markets including the US, Japan and China, the potential EU authorization would expand lecanemab's global footprint substantially. The Nordic commercialization rights held by BioArctic, combined with the planned joint commercialization with Eisai, positions the company for significant revenue potential in this region.

This development strengthens BioArctic's market position in the growing Alzheimer's therapeutics space, particularly as one of few companies with an approved disease-modifying treatment.

The EU market represents a substantial commercial opportunity, with approximately 10.5 million people affected by Alzheimer's disease in Europe. The CHMP's reversal from its previous negative opinion significantly de-risks the EU commercialization pathway. This positive recommendation typically leads to formal approval, opening access to a major market.

BioArctic's strategic partnership with Eisai provides a strong commercialization framework, particularly valuable in the Nordic region where BioArctic holds direct rights. The company's stock could see positive momentum from this news, as EU approval would complete lecanemab's presence in all major pharmaceutical markets globally.

STOCKHOLM, Nov. 14, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai's marketing authorization application (MAA) for lecanemab as treatment of Alzheimer's disease. The recommendation applies to the treatment of early Alzheimer's disease in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. 

The CHMP recommendation for the European Commission to approve lecanemab follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation. A decision from the European Commission is expected within 67 days.

The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) or are non-carriers of the Apolipoprotein E ε4 (ApoE ε4) gene.

"We are very happy and grateful that the CHMP, during their re-examination of lecanemab, has recognized that for the patients in this population, the benefit of the treatment is greater than the risk. We now look forward to the European Commission's decision that is the next step towards providing access to this new treatment for patients in Europe with Alzheimer's disease," said Gunilla Osswald, CEO at BioArctic.

Lecanemab is already approved in the US, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and the Great Britain.

Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer's disease. BioArctic has the rights to commercialize lecanemab in the Nordic region. Currently, BioArctic and Eisai are preparing for joint commercialization in these countries, pending approval from the European Commission.

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on November 14, 2024, at 17:00 CET.

For further information, please contact: 
Oskar Bosson, VP Communications and IR
E-mail:  oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80 

About lecanemab (Leqembi®)
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, United Arab Emirates and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's opinion, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. Clarity AD was a Phase 3 global, placebo-controlled, double-blind, parallel-group, randomized study in 1,795 patients with early AD (MCI or mild dementia due to AD, with confirmed presence of amyloid pathology), of which 1,521 were in the recommended indicated population in the label in the European Union (ApoE ε4 heterozygotes or non-carriers). Of the total number of patients randomized 31% were non-carriers, 53% were heterozygotes and 16% were homozygotes. The treatment group was administered lecanemab 10 mg/kg bi-weekly, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab for 18 months.

The primary endpoint was the global cognitive and functional scale, CDR-SB. In the Clarity AD clinical trial, treatment with lecanemab, in the recommended indicated population (ApoE ε4 heterozygotes or non-carriers), reduced clinical decline on CDR-SB by 33% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.15 with lecanemab and 1.73 with placebo (difference, -0.58; 95% confidence interval [CI], -0.81 to -0.35; P<0.00001). CDR-SB is a global cognitive and functional scale that measures six domains of functioning, including memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care.

In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted 39% less decline compared to placebo at 18 months. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was -3.5 in the lecanemab group and -5.7 in the placebo group (difference, 2.2; 95% CI, 1.3 to 3.1; P<0.00001). The ADCS-MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. 

In the recommended indicated population (ApoE ε4 heterozygotes or non-carriers), the most common adverse reactions were infusion-related reaction (26%), ARIA-H (13%), fall (11%), headache (11%) and ARIA-E (9%).

Eisai has also submitted applications for regulatory approval of lecanemab in 17 other countries and regions, including the European Union. A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024, which was accepted in June 2024. In October 2024, the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was completed in the U.S. under Fast Track status.

Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.

About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) - the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

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CHMP issues positive recommendation for approval of lecanemab in the EU

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SOURCE BioArctic

FAQ

What did CHMP recommend for BioArctic's (BIOA) lecanemab in November 2024?

CHMP issued a positive recommendation for lecanemab as a treatment for early Alzheimer's disease in adult patients who are ApoE ε4 heterozygotes or non-carriers.

In which countries is BioArctic's (BIOA) lecanemab already approved?

Lecanemab is approved in the US, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain.

What are BioArctic's (BIOA) commercial rights for lecanemab?

BioArctic has the rights to commercialize lecanemab in the Nordic region, while Eisai handles commercialization in other markets.

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