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Lundbeck’s Significant Step Forward in Asia

Lundbeck A/S has made a bold move in the fight against migraines by submitting a new drug application (NDA) for Vyepti® (eptinezumab) to Japan's Ministry of Health, Labor and Welfare (MHLW). This critical decision marks a pivotal point for migraine treatment in Asia, as Lundbeck aims to expand access to this innovative preventive medication across crucial markets including China and South Korea.

The acceptance of this application not only represents Lundbeck's strategy to provide effective treatments for migraine sufferers in Asia, but it also addresses a significant healthcare gap in a region where migraine remains underdiagnosed and undertreated. For many patients in countries such as Japan, South Korea, and China, effective preventive treatment options are limited.

According to studies, a staggering proportion of individuals with migraine have never consulted a healthcare professional for their condition. In Japan, it is estimated that between 59.4% to 71.8% of migraineurs have never sought medical help, while in Korea, this figure rises to roughly 75.6%. Shockingly, in China, merely 13.8% of adults living with migraines have received a clinical diagnosis. This underscores the urgent need for better access to treatment options.

Importance of the SUNRISE Trial

Lundbeck's submissions in Asia are reinforced by data from the SUNRISE Phase 3 clinical trial, which has confirmed the efficacy of eptinezumab as a preventive treatment for migraines in Asian populations. The trial has shown promising results, revealing that eptinezumab significantly reduces the frequency of migraine days and is generally well-tolerated, with safety profiles comparable to placebo and existing treatments.

This trial, conducted across several countries including Japan and Korea, involved 983 participants. They were randomly allocated to receive either eptinezumab at doses of 100 mg or 300 mg, or a placebo. The findings affirm the effectiveness of eptinezumab, making it a beacon of hope for those suffering from chronic migraines.

Managing Migraine Effectively

Migraines are recognized as one of the most prevalent neurological disorders, often causing debilitating pain and discomfort, which can lead to significant disruptions in patients' daily lives. The chronic nature of migraine, which encompasses recurrent attacks accompanied by various symptoms such as nausea and light sensitivity, creates not only a personal but also a sociocultural and economic burden.

Increased use of medication for acute migraine attacks can lead to cycles of increased frequency and intensity of migraines, significantly impairing patients' quality of life. Proper preventive treatment options like eptinezumab can change this narrative, mitigating the burden of migraine effectively.

A Commitment to Brain Health

Lundbeck's Chief Development Officer, Johan Luthman, emphasized that the acceptance of these applications is a critical milestone for the company’s Asian development program. He pointed out that eptinezumab holds substantial promise to meet unmet healthcare needs in the region, where treatments for migraine prevention have not reached their potential.

With the potential launch of eptinezumab, Lundbeck aims to enhance management options and improve the lives of countless migraine sufferers in Asia. This progressive approach resonates with Lundbeck’s wider mission to advance brain health and address the pressing challenges faced by patients living with neurological conditions.

Conclusion

The application process for Vyepti® in Japan, China, and South Korea is a landmark move for Lundbeck and reflects its dedication to addressing the healthcare needs of migraine patients in Asia. As the company continues to work closely with regulatory bodies to expedite the treatment's availability, the prospect of effective migraine management for patients in these regions could soon become a reality. Lundbeck is indeed paving the way for a brighter future in brain health, providing hope for those desperately seeking relief from migraines.

For more updates on this and similar topics, keep an eye on Lundbeck’s ongoing commitment to excellence in the field of brain health.