FDA approves Lundbeck?s Vyepti (eptinezumab-jjmr) ? the first and only intravenous preventive treatment for migraine
[caption id="attachment_9277" align="aligncenter" width="1079"] Press Release[/caption]
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
An estimated 700 million people worldwide are living with brain diseases?and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases?? we call this?Progress in Mind.
Read more at?www.lundbeck.com/global/about-us/progress-in-mind.
For additional information, we encourage you to visit our corporate site?www.lundbeck.com?and connect with us on Twitter at?@Lundbeck?and via?LinkedIn.
Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance.
Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.
Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made considering past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.
[i]?VYEPTI (eptinezumab) 2020 Full Prescribing Information.
[ii]?Villal?n CM. The role of CGRP in the pathophysiology of migraine and efficacy of CGRP receptor antagonists as acute antimigraine drugs.?Pharmacol Ther.?2009;124(3):309-323
[iii]?Migraine Research Foundation. Migraine Facts. Available at https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed February 12, 2020.
[iv]?GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990?2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet. 2018; 392: 1789?858
[v]?Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy.?Neurology.?2007;68(5):343-349..
[vi]?Steiner TJ, et al. Migraine is first cause of disability in under 50s: will health politicians now take notice??J Headache Pain. 2018;19(1):17.
H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Denmark
+45 3630 1311
info@lundbeck.com
- In two clinical studies (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), Vyepti met its primary endpoint: decrease in mean monthly migraine days (MMD) over months 1-3.[i]
- A treatment benefit over placebo was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days.i
- In both studies, Vyepti demonstrated a sustained reduction of MMD through the second dose (month 6).i
- Mean migraine frequency at baseline was approximately 8.6 migraine days per month and was similar across treatment groups.i
- Mean change from baseline in MMD with Vyepti compared with placebo months 1-3: -3.9 days for 100 mg (p=0.018), -4.3 days for 300 mg (p<0.001), and -3.2 days for placebo.i
- Percent responders with at least 50 percent reduction in MMD in months 1-3 compared with placebo: 49.8 percent for 100 mg (nominal statistical significance p=0.009), 56.3 percent for 300 mg (p<0.001), and 37.4 percent for placebo.i
- Percent responders with at least 75 percent reduction in MMD in months 1-3: 22.2 percent for 100 mg (p=NS*), 29.7 percent for 300 mg (p<0.001), and 16.2 percent for placebo.i
- Greater percentage of placebo-treated patients had migraine on most days during the first 7 days of treatment compared to Vyepti -treated patients.i
- Mean migraine frequency at baseline was approximately 16.1 migraine days per month and was similar across treatment groups.i
- Mean change from baseline in MMD compared with placebo months 1-3: -7.7 days for 100 mg (p<0.001), -8.2 days for 300 mg (p<0.001), and -5.6 days for placebo.i
- Percent responders with at least 50 percent reduction in MMD in months 1-3 compared with placebo: 57.6 percent for 100 mg (p<0.001), 61.4 percent for 300 mg (p<0.001), and 39.3 percent for placebo.i
- Percent responders with at least 75 percent reduction in MMD in months 1-3: 26.7 percent for 100 mg (p<0.001), 33.1 percent for 300 mg (p<0.001), and 15.0 percent for placebo.i
- Greater percentage of placebo-treated patients had migraine on each individual day during the first 7 days of treatment compared to Vyepti-treated patients.i
Investors: | Media: |
Palle Holm Olesen | Mads Kronborg |
Vice President, Investor Relations | Senior Director, Corporate Communication |
palo@lundbeck.com | mavk@lundbeck.com |
+45 30 83 24 26 | +45 36 43 40 00 |
US media: | |
Ashleigh Duchene | |
Director,?External Affairs & Patient Advocacy | |
aduc@lundbeck.com | |
+1 312 802 2906 |
Attachment