#South Korea #Seoul #Lundbeck #Migraine #Vyepti

Lundbeck Secures Marketing Authorization for Vyepti® in South Korea

On May 26, 2026, H. Lundbeck A/S announced that South Korea's Ministry of Food and Drug Safety (MFDS) has granted marketing authorization for Vyepti® (eptinezumab), a monoclonal antibody intended for the preventive treatment of migraine in adults. This significant milestone offers a new avenue for individuals suffering from migraines, a condition affecting 11% of the South Korean population, causing debilitating symptoms and limitations on daily life.

Understanding Migraine

Migraine is a neurological disorder known for its recurrent and severe headache episodes, which are commonly accompanied by nausea, vomiting, and heightened sensitivity to light and sound. Despite its high prevalence, preventive treatments for migraine are significantly underutilized. Patients often face barriers such as misdiagnosis, limited access to care, and insufficient treatment options, underscoring the importance of new therapeutic strategies.

Lundbeck's Johan Luthman, EVP and Head of Research and Development, emphasized the impact of Vyepti's approval, stating, "This approval marks an important milestone for people living with migraine in Korea, many of whom remain underserved by existing preventive options."

The Role of Vyepti® (eptinezumab)

Eptinezumab is a humanized monoclonal antibody that specifically targets the calcitonin gene-related peptide (CGRP), a protein involved in migraine pathophysiology. The drug is designed for intravenous administration and has demonstrated efficacy in reducing monthly migraine days through various Phase 3 trials, including the SUNRISE trial, which particularly focused on a predominantly Asian population.

The efficacy was evident: both PROMISE-1 and PROMISE-2 trials confirmed that eptinezumab significantly decreased migraine frequency in adult patients suffering from episodic and chronic migraines. Notably, effects were observed as early as the first day post-infusion, providing rapid relief to patients. Moreover, the safety profile of eptinezumab was established through extensive clinical trials involving over 2,000 subjects, highlighting common side effects such as nasopharyngitis and hypersensitivity.

The Need for New Migraine Treatments

Currently, migraine remains one of the leading causes of disability worldwide, significantly impacting the productivity, social interactions, and overall quality of life for millions. Repeated migraine attacks can lead to a cascade effect: increased dependency on acute medication may aggravate symptoms and worsen the condition, underscoring the urgent need for effective preventive strategies.

Lundbeck's Commitment to Brain Health

Lundbeck has long been a leader in neurology and psychiatry, solely focused on enhancing brain health for over 70 years. With the introduction of Vyepti in South Korea, Lundbeck demonstrates its commitment to tackling the challenges associated with migraine management. The company has previously secured approvals in the United States and the European Union, and its products are now available in more than 30 markets globally.

As migraines continue to impose a significant societal burden, Vyepti's authorization in South Korea is not only timely but crucial for patients in need of targeted and effective preventive therapies. Lundbeck's ongoing dedication to advancing treatment solutions reflects its mission to improve the lives of those affected by neurological disorders, paving the way for a future with enhanced brain health and well-being.

For more information about Lundbeck and its innovations in brain health, visit Lundbeck’s official website.