Leqembi is a new treatment that has just been approved by the FDA for Alzheimer’s1. However, a drug of this caliber will always face tumultuous FDA challenges due to its complexity and potential risks to patients2. For EMMA International , this highlights the importance of robust clinical trial design. EMMA’s clinical expertise ensures compliance with FDA standards, helping companies present solid evidence to secure approvals3.
One of the main concerns with Leqembi was safety, as it carries the risk of brain swelling or bleeding4. EMMA International can help companies address these concerns by creating a comprehensive risk management plan and ensuring ongoing safety monitoring5. This is critical for satisfying FDA standards and ensuring the drug makes it to market6. Although Leqembi was granted accelerated approval, post-market studies are required for continued approval. These additional studies fall within EMMA International’s area of expertise.
Leqembi’s approval shows how difficult it is to bring new treatments to market. EMMA International offers guidance to navigate these challenges, from clinical trials to market access. Contact us today at 248-987-4497 or via email at info@emmainternational.com.
References
1. U.S. Food and Drug Administration. (2023). FDA Grants Accelerated Approval for Alzheimer’s Drug Leqembi. Retrieved from https://www.fda.gov
2. Cummings, J., et al. (2023). Challenges in Alzheimer’s Drug Development: Lessons from Leqembi. Alzheimer’s Research & Therapy, 15(1), 12-19.
3. U.S. Department of Health and Human Services. (2023). Clinical Trial Requirements for Drug Approval. FDA Guidance Documents. Retrieved from https://www.fda.gov
4. Leqembi Prescribing Information. (2023). Eisai Co., Ltd. & Biogen Inc. Retrieved from https://www.leqembi.com
5.National Institute on Aging. (2023). Understanding Risks of Alzheimer’s Treatments. Retrieved from https://www.nia.nih.gov
6. FDA. (2023). Post-Market Surveillance and Safety Reporting for Drugs. FDA Regulations. Retrieved from https://www.fda.gov