|Amarin Corporation plc (ADR) (NASDAQ:AMRN) confirms Anchor CRL from FDA|
|By Marilyn Mullen|
|Tuesday, 28 April 2015 13:47|
Amarin Corporation plc (ADR) (NASDAQ:AMRN) has confirmed receiving the much waited Complete Response Letter (CRL) from U.S. Food and Drug Administration (FDA) for the Vascepa capsules ANCHOR trial supplemental New Drug Application (sNDA).
Vascepa is FDA approved for possible use as adjunct to diet for reducing triglyceride levels in adult patients having excess hypertriglyceridemia.
The present Vascepa labeling would not change. The ANCHOR sNDA will look to expand approved Vascepa labeling for including an adjunct for reducing TG levels in adult patients on statin therapy with mixed dyslipidemia as well as triglyceride levels from 200 to 499 mg/dL.
CRL was expected in last few months after the company’s determination for not further appealing October 2013, FDA ANCHOR Special Protocol Assessment (SPA) agreement after denial and reconsideration of rescission appeal at three levels of augmenting authority within the FDA.
The initially assigned Prescription Drug User Fee Act goal date was December 20, 2013.
FDA accepted that Vascepa gave treatment difference demonstrating lower TG levels vis-à-vis placebo in patients treated in ANCHOR study.
FDA has concluded that there is not sufficient data currently for supporting drug-induced change in serum TGs as surrogate for lowering cardiovascular risk in ANCHOR population. However, it didn’t assess the drug-induced effects of Vascepa will not actually lower cardiovascular risk in this population.
Amarin had given a number of alternative indications as well as data presentations besides regulatory pathways for approval under sNDA but FDA did not provide approval considering ANCHOR clinical trial efficacy data at this time.
In an earlier dialogue with Amarin, FDA was stated that Amarin should complete ongoing REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial) cardiovascular outcomes study.
FDA said to Amarin in CRL that it is expecting the final results from REDUCE-IT trial to satisfy FDA’s uncertainty pertaining to benefits of drug-induced changes in lipid parameters on cardiovascular risk in the ANCHOR population.