PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.
Joseph S. Zakrzewski, CEO, commented on the timing for the filing of the sNDA for the use of Vascepa to treat patients on statin therapy. He stated, "Continuing with the regulatory update. We have drafted the sNDA for the ANCHOR indication, that is the use of Vascepa to treat patients on Statin therapy with multiple lipid disorders, including triglyceride levels greater than 200 mg/dL. Our submission of this sNDA to FDA is pending only the final REDUCE-IT cardiovascular outcome study being deemed substantially under way as discussed with the FDA in connection with our ANCHOR Special Protocol Assessment. Patient enrollment in the REDUCE-IT study is progressing well and, as previously guided, we anticipate submitting this sNDA submission no later than the end of February 2013, which would position the sNDA for PDUFA date in the fourth quarter of 2013."
Source: Q3 2012 earnings conference call, 11/08/12.
Joseph S. Zakrzewski, CEO, gave guidance for the filing of the sNDA for high triglycerides mixed dyslipidemia indication for Vascepa (AMR-101). He stated, "Looking ahead, now that Vascepa is approved for the initial indication, Amarin is preparing to file a supplementary NDA, an sNDA for the high triglycerides mixed dyslipidemia indication studies in the ANCHOR phase 3 trial. The sNDA can be filed when the Amarin’s cardiovascular outcomes study REDUCE-IT is substantially underway, which as previously stated, we expect to achieve in 2012."
Source: Q2 2012 earnings conference call, 8/08/12.
Vascepa regulatory update
On July 26, 2012, the U.S. Food and Drug Administration (FDA) approved Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG > 500mg/dL) hypertriglyceridemia. The most commonly reported adverse reaction in Vascepa treated patients was arthralgia.
Consistent with prior guidance, Amarin plans to file a supplemental NDA (sNDA) for the use of Vascepa in the patient population studied in Amarin's ANCHOR Phase 3 trial. Prior to filing this sNDA, the FDA requires that Amarin's cardiovascular outcomes study, REDUCE-IT, be substantially underway. As previously stated, Amarin anticipates this planned sNDA submission to result in a Prescription Drug User Fee Act (PDUFA) action date for the ANCHOR sNDA in the second half of 2013.
Source: press release, 8/08/12. http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=699335
|Vascepa (AMR-101)||Cardiovascular||Hyperlipidemia||Omega-3 fatty acid||Plasma lipid|
Mechanism of action: Vascepa (AMR-101) is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl) for the treatment of patients with very high triglyceride levels (≥500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (≥200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia).
Phase of Development: Approved in U.S.
Event Type: Regulatory FDA: sNDA submission
Dates: 2013-01-01 - 2013-02-28
February 26, 2013
Amarin Announces Submission of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High Triglycerides With Mixed Dyslipidemia
BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and < 500 mg/dL) with mixed dyslipidemia. Amarin expects to hear within 74 days from the FDA whether the sNDA submission has been accepted for review (inclusive of the standard 60-day review and the standard 14-day communication periods).
"This submission marks another significant milestone achieved for Amarin. Data from our pivotal Phase 3 placebo-controlled ANCHOR study showed that Vascepa is unique in that it significantly lowered both triglycerides and LDL-cholesterol on top of optimized statin therapy and exhibited a safety and tolerability profile similar to placebo, unlike the clinical results of other triglyceride-lowering therapies," said Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The submission of this sNDA for Vascepa follows the FDA approval and recent launch of Vascepa for use as an adjunct to diet to lower triglyceride levels in adult patients with severe (TG ≥500 mg/dL) hypertriglyceridemia. If approved for the ANCHOR indication, Vascepa will be the only approved prescription omega 3 therapy for cardiovascular health management in this patient population (TG ≥200 mg/dL and < 500 mg/dL with mixed dyslipidemia) and will represent the next generation of lipid management for potentially millions of patients."
Source: press release, 1/26/13. http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=743096