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 Rastogi3 days ago

NEWS

Merz Therapeutics Enrolls First Patients in P-III Studies Evaluating Xeomin for Migraine Prevention

Shots: Merz Therapeutics has enrolled the first patients in two global P-III studies, MINT-E (episodic migraine, ~990 pts) and MINT-C (chronic migraine, ~780 pts), evaluating the efficacy and safety of Xeomin (incobotulinumtoxinA) for migraine prevention Both studies will recruit ~1,770 adults across 120 sites in North America & Europe, and recruitment in Europe is expected…

ByPrince GiriAugust 26, 2025

NEWS

AbbVie Reports Topline P-III (TEMPLE) Trial Data on Qulipta (Atogepant) for Migraine Prevention

Shots: The P-III (TEMPLE) trial assessed Qulipta (60mg, QD) vs the highest tolerated dose of topiramate (50, 75 or 100mg; QD) over 24wks. in 545 adults with ≥4 monthly migraine days (MMD) across 73 sites in the EU, Israel & Canada, followed by a 52wk. open-label phase, where all pts received Qulipta Trial met its…

ByRidhi RastogiJune 19, 2025

NEWS

Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

Shots: The US FDA has approved 505(b)(2) NDA of Atzumi (STS101) nasal powder for the acute treatment of migraine with or without aura in adults Approval was based on a P-I PK trial & P-III (ASCEND) trial, both showing fast absorption, rapid high DHE levels, & sustained DHE plasma concentrations over time Atzumi utilizes SMART…

ByRidhi RastogiMay 1, 2025

NEWS

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Shots: The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77%…

ByDipanshu DixitJanuary 31, 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

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

Merz Therapeutics Enrolls First Patients in P-III Studies Evaluating Xeomin for Migraine Prevention

AbbVie Reports Topline P-III (TEMPLE) Trial Data on Qulipta (Atogepant) for Migraine Prevention

Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat 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

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

Contact US

OUR INFORMATION

FOLLOW US