Boston, MA 09/15/2014 (wallstreetpr) – A late-stage biopharmaceutical company, Amarin Corporation plc (ADR) (NASDAQ:AMRN) disclosed that the Food and Drug Administration or FDA’s Office of New Drugs or OND has denied its appeal of the regulator’s rescission of the ANCHOR clinical study Special Protocol Assessment or SPA deal. The company has appealed for the restoration of SPA agreement as it covered third stage ANCHOR trial of its prescription drug, Vascepa.
SPA Agreement
The Amarin Corporation plc (ADR) (NASDAQ:AMRN) said that it continued to believe that restoration of the SPA agreement along with an indication based on a trial result of ANCHOR was in the interest of patient care, a press statement from the company indicated. Therefore, it was evaluating the response of OND and the possible next steps.
Amarin had earlier indicated that it was going to be a tough proposition to reinstate SPA agreement though it had full confidence in its scientific, legal, and regulatory appeal arguments. Therefore, it seems that the company has expected such an outcome from the FDA.
However, it is yet to hear FDA’s determination on its ANCHOR supplemental new drug application or sNDA, which was pending with the regulator.
Vascepa
Amarin Corporation plc (ADR) (NASDAQ:AMRN) said that its Vascepa continued to remain FDA approved and marketed drug for use as an addition to diet to cut down the levels of triglyceride in adult patients. It as also called as AMR101 in the scientific literature and a highly pure EPA omega-3 prescription drug of one gram.
The Vascepa effect on the cardiovascular mortality and pancreatitis risk besides morbidity in patients with hypertriglyceridemia were not determined. The company indicated that the most commonly reported adverse type of reaction was arthralgia, i.e. 2.3% for Vascepa compared to 1.0% for placebo.
The drug was given to patients, who have indications of known hypersensitivity like anaphylactic reaction to the pill or any of its components. Amarin Corporation plc (ADR) (NASDAQ:AMRN) also said that patients, who have hypersensitivity to shellfish or and fish, should use the drug with caution.
