Just got this boilerplate response. FYI.
Thank you for your email of July 22, 2014, to Drs. Jenkins and Woodcock at the Food and Drug Administration (FDA or Agency) regarding Amarin’s Special Protocol Assessment (SPA) for its drug, Vascepa (icosapent ethyl). This response is sent on their behalf from the Division of Drug Information.
Amarin’s application for Vascepa for concomitant use with a statin to reduce triglyceride (TG) levels in adults with TG levels of 200-499 mg/dL (referred to as the “ANCHOR” study or indication) is still pending, as FDA has not yet made a decision on the application. Furthermore, several pending citizen petitions have been submitted to FDA that raise similar concerns regarding Amarin’s SPA agreement. Information on applications and citizen petitions pending before the Agency is confidential. Thus, with the exception of the information publicly disclosed at the October 16, 2013, Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting, federal law generally prohibits FDA from discussing Amarin’s pending application and the pending citizen petitions with third parties.
Please know that FDA is aware of the significant Congressional and stakeholder interest in the Agency’s decision on this matter, and is making every effort to resolve the matter as expeditiously as possible, while also ensuring that the Agency’s decision reflects a full consideration of the issues brought to our attention in light of all the available scientific evidence.
Thank you for contacting us.
Best regards,
CCL
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration