Amarin Corp. (AMRN) Announces VAZKEPA Receives Regulatory Approval in Switzerland
Get Alerts AMRN Hot Sheet
Join SI Premium – FREE
Amarin Continuing Process for Obtaining National Pricing and Reimbursement in Switzerland in the Course of 2023 --
-- Swissmedic Approval Underpins Company’s Presence and Expansion in Switzerland as its Regional Commercial Hub for Europe --
Amarin Corporation plc (NASDAQ: AMRN) today announced that Switzerland’s Swissmedic has granted approval to VAZKEPA (icosapent ethyl). Swissmedic approved VAZKEPA to reduce risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1.
In parallel with the regulatory submission, Amarin had already initiated the process for obtaining national pricing and reimbursement in Switzerland, which is expected to conclude in the course of 2023.
According to the European Heart Network, the burden of cardiovascular disease (CVD) is greater than that of any other disease and the leading cause of death in Europe and in the world. 60 million people are living with CVD in the EU, with 13 million new cases of CVD each year2. Also in Switzerland, cardiovascular diseases are the most common cause of death – and the third most common cause of hospitalization – in the country3.
“This latest regulatory approval of VAZKEPA in Switzerland not only underscores the urgent need for proven therapies to help address residual cardiovascular risk for patients globally, it is also another example of an international health authority recognizing the value of our robust scientific evidence and innovative treatment to meet this need,” said Steven Ketchum, PhD., President, Research & Development and Chief Scientific Officer, Amarin.
The approval in Switzerland marks the sixth approval for the VASCEPA/VAZKEPA franchise within 2022. The approval also underpins the importance of Switzerland for Amarin’s European operations, having established its European Regional Hub in Zug, Switzerland in 2021. Today, the Company’s Zug office is the home to over 30 employees covering both local Swiss commercial and medical roles as well as global and regional roles providing support for the European teams.
Laurent Abuaf, SVP and President Amarin Europe: “Today’s regulatory approval of VAZEKPA in Switzerland is an important step as we seek national pricing and reimbursement and consider building out our local Swiss operations in support of a commercial launch in 2023. Switzerland is one of the most reputable and innovative biotech hubs in the world, with over 1,000 biotech and leading healthcare companies being based here. This provides companies such as Amarin with access to a tremendous talent pool that we are leveraging today in our regional hub to enable launch acceleration across Europe.”
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Alvotech (ALVO) signs U.S. agreement to expand access for adalimumab
- Baozun Inc. (BZUN) Chairman Issues 2023 Letter to Shareholders
- Evotec (EVO) And Variant Bio Enter Strategic Partnership To Discover And Develop Fibrosis Treatments
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!