- Commercial-stage biotech Amarin Corporation ( NASDAQ: AMRN ) announced Tuesday that the health regulators in Australia approved its fish oil-derived therapy Vascepa/Vazkepa to lower cardiovascular (CV) risk in certain patients with high lipid levels.
- The decision by the Therapeutic Good Administration (TGA) allows the company to market the treatment, also known as icosapent ethyl, to cut the risk of CV events in adults with elevated triglycerides despite prior treatment with statins.
- The approval “marks important progress for patients in that country with unmet need to address residual cardiovascular risk as well as for Amarin’s efforts to expand access to VAZKEPA across global markets,” R&D and Chief Scientific Officer of Amarin ( AMRN ) Steven Ketchum said.
- Australia is the fifth key international market to approve Vascepa/Vazkepa in 2022, Amarin ( AMRN ) said, adding that its patent rights extend market exclusivity for the product in the country into early 2030.
- The Dublin, Ireland-based company topped Street forecasts with its recent Q3 2022 financials.
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Amarin wins regulatory nod in Australia for heart disease therapy