Lundbeck Reports the MHLW Approval of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has approved Vyepti (eptinezumab) for the prevention of migraine attacks in adults Approval was backed by extensive clinical data, incl. P-III (PROMISE-1, PROMISE-2 & DELIVER) studies as well as P-III (SUNRISE) trial, which assessed Vyepti in a predominantly Asian population; NDA was further supported by the SUNSET LTE trial conducted in Japanese…

ByRidhi RastogiSeptember 16, 2026

NEWS

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO…

ByRidhi RastogiNovember 14, 2025

VIEWPOINTS

Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

Shots: Marija Geertsen shares the highlights of the data presented at the 65th AHS annual meeting, including insights from real-world experience with VYEPTI's review study With a focus on the review study that delved into the experiences of 94 patients receiving VYEPTI treatment, Marija provides an in-depth account of the PROMISE 1 and PROMISE 2…

BySaurabh ChaubeyNovember 6, 2023

VIEWPOINTS

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Shots: Marija spoke about the data on Migraine and Brain Health presented at the 75th Annual Meeting of the AAN 2023. The 12 abstracts included the data from post-hoc and real-world analyses of VYEPTI She also talked about a medical symposium sponsored by the company “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening…

BySenior EditorAugust 14, 2023

VIEWPOINTS

Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022

Shots: Rami spoke about study design of the P-III study evaluating its lead candidate in migraine Marija Geertsen talked about different treatment options available for migraine & neurological diseases The interview highlights the development plans and global expansion of various therapies for brain diseases Smriti: Explain the details (MOA, ROA, formulations, etc.) of Vyepti. Rami Apelian: VYEPTI®…

BySenior EditorAugust 29, 2022

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health care The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan…

BySenior EditorMarch 27, 2020

Lundbeck Reports the MHLW Approval of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022

Insights+: The US FDA New Drug Approvals in February 2020

Contact US

FOLLOW US