BioArctic AB
🇸🇪Sweden
- Country
- 🇸🇪Sweden
- Ownership
- Public
- Established
- 1992-01-01
- Employees
- 88
- Market Cap
- -
- Website
- http://www.bioarctic.se
BioArctic Expands Exidavnemab Phase 2a Trial to Include Multiple System Atrophy Patients
• Regulatory authorities in Spain and Poland have approved the inclusion of Multiple System Atrophy (MSA) patients in BioArctic's ongoing EXIST Phase 2a trial of exidavnemab, an alpha-synuclein antibody.
• The expanded trial will recruit 12 MSA patients in addition to the 24 participants with Parkinson's disease, evaluating safety, tolerability, and biomarkers in plasma, cerebrospinal fluid, and through digital measurements.
• MSA is a rapidly progressive, fatal rare disease with no current treatments to slow progression, affecting fewer than 42,000 people in the U.S. with patients typically surviving only 6-10 years after symptom onset.
FDA Grants Orphan Drug Designation to BioArctic's Exidavnemab for Multiple System Atrophy
• The US FDA has granted orphan drug designation to exidavnemab, BioArctic's monoclonal antibody targeting alpha-synuclein aggregates, for the treatment of Multiple System Atrophy.
• Multiple System Atrophy is a rapidly progressive, fatal rare disease affecting fewer than 42,000 people in the US, with patients typically surviving only 6-10 years after symptom onset.
• The orphan designation provides BioArctic with significant development incentives, including tax credits for clinical trials, user-fee exemptions, and potential seven-year marketing exclusivity upon approval.
FDA Approves Monthly IV Maintenance Dosing for Leqembi, Eases Treatment Burden for Alzheimer's Patients
• The FDA has approved a monthly intravenous (IV) maintenance dose for Leqembi, offering a more convenient treatment schedule for early Alzheimer's disease.
• Patients completing the initial 18-month biweekly IV treatment can transition to monthly dosing, potentially improving long-term adherence and quality of life.
• Approval is based on data modeling showing sustained clinical and biomarker benefits with monthly dosing, addressing the continuous neurotoxic processes of Alzheimer's.
• Leqembi, developed by Eisai and Biogen, is now approved in multiple countries, offering a significant advancement in managing early Alzheimer's disease.
Eisai and Biogen Launch Alzheimer's Drug Leqembi in South Korea
• Eisai and Biogen have launched Leqembi in South Korea for adults with mild cognitive impairment or early Alzheimer's disease.
• Leqembi targets amyloid-beta aggregates, reducing plaques in the brain and slowing the progression of Alzheimer's disease.
• Clinical trials demonstrated Leqembi reduced the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, delaying disease progression.
• Eisai Korea is also seeking approval for a subcutaneous autoinjector to allow for convenient weekly self-administration of Leqembi.
Lecanemab Approved in Mexico for Early Alzheimer's Disease Treatment
• Lecanemab (LEQEMBI®) has been approved in Mexico for treating early Alzheimer's disease by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS).
• The approval was based on Phase 3 Clarity AD study results, demonstrating statistically significant outcomes in primary and key secondary endpoints.
• Lecanemab selectively targets and reduces soluble amyloid-beta aggregates and insoluble plaques in the brain, slowing cognitive and functional decline.
• Eisai and Biogen will co-commercialize and co-promote Lecanemab in Mexico, where an estimated 1.3 million people suffer from Alzheimer's.
CHMP Recommends Approval of Lecanemab for Early Alzheimer's in the EU
• The Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for lecanemab to treat early Alzheimer's in the EU.
• The recommendation applies to adult patients with mild cognitive impairment or mild dementia due to Alzheimer's disease who are ApoE ε4 heterozygotes or non-carriers.
• Lecanemab, developed through a collaboration between BioArctic and Eisai, has demonstrated a reduction in clinical decline in early Alzheimer's patients.
• The European Commission is expected to make a final decision within 67 days, potentially expanding access to this treatment in Europe.
EU Review of Lecanemab for Early Alzheimer's Faces Further Scrutiny
• The European Commission has requested further review of lecanemab's safety data by the CHMP after its initial positive opinion in November 2024.
• The CHMP will assess new safety information and the clarity of risk minimization measures at its February 2025 meeting.
• Eisai and Biogen affirm that post-launch safety data from the U.S., Japan, and other countries align with approved labels, with no new safety signals detected.
• Both companies are committed to addressing the EC's requests and delivering lecanemab to EU patients with early Alzheimer's as quickly as possible.
CHMP Recommends Approval of Lecanemab for Early Alzheimer's Treatment in the EU
• The European Medicines Agency's CHMP has recommended lecanemab for treating early Alzheimer's in ApoE ε4 heterozygotes or non-carriers.
• The recommendation follows a re-examination of Eisai's marketing authorization application, with a European Commission decision expected within 67 days.
• Lecanemab, developed through a BioArctic and Eisai collaboration, has shown a 33% reduction in clinical decline in early Alzheimer's patients.
• Lecanemab is already approved in the US, Japan, China, South Korea, and other countries, marking a significant step in Alzheimer's treatment.
CHMP Recommends Lecanemab for Early Alzheimer's Treatment in the EU
• The Committee for Medicinal Products for Human Use (CHMP) has recommended lecanemab for treating early Alzheimer's disease in adult patients in the EU.
• The recommendation is specifically for patients with mild cognitive impairment or mild dementia due to Alzheimer's who are ApoE ε4 heterozygotes or non-carriers.
• Lecanemab, developed through a collaboration between BioArctic and Eisai, is already approved in several countries, including the US, Japan, and China.
• The European Commission is expected to make a final decision on lecanemab's approval within 67 days, potentially expanding access to this new treatment.
EU Backs Eisai's Leqembi for Alzheimer's in Reversal of Earlier Rejection
• The European Medicines Agency's advisory panel has reversed its initial negative decision and now supports the use of Eisai's Leqembi for treating Alzheimer's disease.
• Leqembi's use will be restricted to patients with one or no copy of the ApoE4 gene variant due to the increased risk of brain swelling and bleeding in those with two copies.
• This decision marks a significant win for Eisai and its partners Biogen and BioArctic, potentially benefiting millions of Alzheimer's patients in Europe.
• Leqembi has already been approved in the US, Japan, and China, and this EU backing could account for up to 30% of the drug's worldwide peak sales.
CHMP Recommends Approval of Lecanemab for Early Alzheimer's in the EU
• The CHMP has recommended lecanemab for treating early Alzheimer's disease in ApoE ε4 heterozygotes or non-carriers.
• The recommendation follows a re-examination of Eisai's marketing authorization application after an initial negative recommendation.
• Lecanemab demonstrated a 33% reduction in clinical decline on the CDR-SB scale compared to placebo in clinical trials.
• Lecanemab is already approved in the US, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain.
CHMP Recommends Approval of Lecanemab for Early Alzheimer's Treatment in the EU
• The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of lecanemab for treating early Alzheimer's disease in the EU.
• The recommendation applies to adult patients with mild cognitive impairment or mild dementia due to Alzheimer's who are ApoE ε4 heterozygotes or non-carriers.
• Lecanemab has demonstrated a reduction in clinical decline by 33% compared to placebo in the Clarity AD clinical trial over 18 months.
• BioArctic and Eisai are preparing for joint commercialization in the Nordic region, pending the European Commission's final decision.
Eisai Submits BLA for Subcutaneous Leqembi Maintenance Dosing in the US
• Eisai has completed its Biologics License Application (BLA) submission to the FDA for a subcutaneous autoinjector of Leqembi (lecanemab) for weekly maintenance dosing.
• The BLA is supported by data from the Clarity AD open-label extension study, aiming to provide a more convenient administration route for Alzheimer's patients.
• If approved, the Leqembi autoinjector could allow for at-home or in-clinic administration, potentially reducing hospital visits and improving patient convenience.
• Leqembi is currently approved in multiple countries for treating early Alzheimer's disease, with ongoing applications in other regions, including the European Union.
Eisai Submits BLA for Subcutaneous Leqembi Maintenance Dosing in the US
• Eisai has completed the submission of a Biologics License Application (BLA) to the FDA for a subcutaneous autoinjector of Leqembi (lecanemab).
• The BLA seeks approval for weekly maintenance dosing of Leqembi via subcutaneous injection for Alzheimer's disease patients with mild cognitive impairment.
• The submission is based on data from the Clarity AD open-label extension study, with the autoinjector offering a 15-second administration time.
• If approved, the subcutaneous formulation would provide a more convenient administration route, potentially reducing hospital visits and improving patient compliance.
Lecanemab Shows Sustained Cognitive Benefits in Early Alzheimer's with Long-Term Treatment
• Three-year data reveals that lecanemab continues to provide increased patient benefit for individuals with early Alzheimer's disease, showing approximately a 1-point expansion on the CDR-SB scale compared to the ADNI population.
• A subset of patients with low levels of brain amyloid at the start of lecanemab treatment demonstrated improved or maintained cognition and function after three years, suggesting early intervention benefits.
• Continued lecanemab treatment showed no new safety concerns, with most ARIA events occurring in the first six months and decreasing thereafter, indicating a manageable long-term safety profile.
• Data suggest that Alzheimer's disease progression continues even after plaque clearance, supporting the need for continued treatment with lecanemab to prevent amyloid reaccumulation and worsening of plasma biomarkers.
Eisai Seeks FDA Approval for Subcutaneous Lecanemab in Alzheimer's Maintenance Therapy
• Eisai initiates a rolling submission to the FDA for a subcutaneous formulation of Lecanemab (Leqembi) for weekly maintenance dosing in early Alzheimer's disease.
• The subcutaneous version offers a more convenient administration route via autoinjector, potentially reducing hospital visits and easing the burden on patients and caregivers.
• The submission is supported by Phase 3 Clarity AD study data, aiming to sustain clearance of toxic amyloid-beta protofibrils with weekly 360 mg doses after IV initiation.
• Lecanemab, already approved for bi-weekly IV treatment, seeks to expand its accessibility following the discontinuation of Aduhelm, with potential for at-home administration.
EMA's Advisory Group to Review Lecanemab for Alzheimer's Treatment
• The European Medicines Agency's (EMA) Scientific Advisory Group (SAG) will discuss the marketing authorization application for lecanemab.
• Lecanemab, developed by BioArctic and Eisai, is under review for treating Alzheimer's disease.
• The European Commission's decision on lecanemab is expected in the second quarter of 2024, pending CHMP opinion.
• Lecanemab has already been approved in the United States, Japan and China for mild cognitive impairment and mild dementia due to Alzheimer's disease.
FDA Accepts sBLA for Traditional Approval of LEQEMBI for Alzheimer's Disease Treatment
The U.S. Food and Drug Administration (FDA) has accepted Eisai's supplemental Biologics License Application (sBLA) for LEQEMBIâ„¢ (lecanemab-irmb) for traditional approval, based on Phase 3 Clarity AD data. LEQEMBI, approved under the Accelerated Approval Pathway for Alzheimer's Disease, targets amyloid beta plaques. The FDA has granted Priority Review with a PDUFA action date of July 6, 2023.
FDA Grants Priority Review to Lecanemab for Early Alzheimer's Treatment
• The FDA has accepted Eisai's Biologics License Application (BLA) for lecanemab, an anti-amyloid beta protofibril antibody, for treating mild cognitive impairment due to Alzheimer's disease.
• Lecanemab has been granted Priority Review, setting a PDUFA action date for January 6, 2023, potentially expediting access for patients with early Alzheimer's.
• The ongoing Clarity AD Phase 3 trial results will serve as the confirmatory study for lecanemab's clinical benefit, with Eisai planning to seek traditional approval by early 2023.
• Lecanemab targets soluble toxic amyloid-beta aggregates, aiming to slow the progression of Alzheimer's, and has received Breakthrough Therapy and Fast Track designations from the FDA.
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