FDA denies appeal of its rescission of the ANCHOR trial Special Protocol Assessment (SPA) agreement
The Office of New Drugs (OND) within the FDA has denied Amarin's appeal of FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement. Amarin had previously expressed that while it believes strongly in its legal, scientific and regulatory appeal arguments that it would be an uphill battle to achieve an SPA agreement reinstatement. Amarin continues to believe that reinstatement of this SPA agreement and approval of an indication based on the ANCHOR clinical trial results is in the best interest of patient care and is evaluating OND's response and potential next steps. Amarin has not yet received a determination from FDA on the pending ANCHOR supplemental new drug application (sNDA).
- Vascepa remains FDA approved and marketed for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia.