Amarin Corp Plc (AMRN)

[HDGabor]

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Noting special, resubmit sNDA 005 with R-IT data and request Class 1 classification. 21CFR314.110:

b) Applicant actions. After receiving a complete response letter, the applicant must take one of following actions:

(1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter.

(i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission.

(ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.

(iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission.

From CRL:

Given the current level of uncertainty regarding the benefits of drug-induced changes in lipid/lipoprotein parameters on CV risk among statin-treated patients with residually high TG (200-499 mg/dL), you will need to provide evidence that Vascepa reduces the risk of major adverse CV events in patients at high risk for cardiovascular disease, at LDL-C goal on statin therapy, with residually high TG. We anticipate that the final results from the REDUCE-IT trial could be submitted to satisfy this deficiency.

Best,
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