Amarin Aims Vascepa For The Sweet Spot Of Dyslipidemia
FDA leaves door open to modify label of Amarin’s omega-3 fatty acid therapy Vascepa prior to approval in a healthier population, says company CEO. Per the current label, triglycerides are lowered significantly with no increase in LDL cholesterol, a potential differentiating point from Pronova/Glaxo’s blockbuster EPA/DHA therapy Lovaza.
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FDA Gives Metabolism/Endocrinology Division An Acting Director
Diabetes team leader Jean-Marc Guettier is detailed to replace Mary Parks as director of the Division of Metabolism and Endocrinology Products on a temporary basis as she moves up to Deputy Director of the Office of Drug Evaluation II.
ANCHOR Indication For Amarin’s Vascepa Will Face FDA Panel Scrutiny
Key question at the Oct. 16 advisory committee review could be whether FDA should wait for results from an ongoing cardiovascular outcomes trial before significantly broadening the prescription fish oil product’s approval to include adults with high triglycerides and mixed dyslipidemia.
Amarin Raises $100M Debt Funding As It Preps For Vascepa Launch
With no partner or buyer ready to complete a transaction, Amarin prepares to market an approved fish-oil pill on its own. A new hybrid debt vehicle will tide it over until it receives more clarity around an NCE designation and a second indication, which it hopes could eventually lead to a deal.