On November 10, the company announced results for its fish oil drug Vascepa, which is used in the REDUCE-IT study. The company stated that Vascepa reduced the risk of major cardiovascular events by 25% in statin-treated patients at elevated risk with increased triglycerides. This includes a 20% reduction in cardiovascular deaths.
Even though the results showed improvement in patients with higher triglyceride levels, Amarin was questioned for its choice of placebo as a control in the study and researchers were concerned that the use of mineral oil could have bettered the Vascepa’s results.
In an interview to CNBC, Amarin’s CEO John Thero stated that the mineral oil was reviewed and approved by FDA prior to the study. He also expressed his confidence in Vascepa by saying that people will appreciate what Vascepa will do once they understand the company’s data better. It is also expected that majority of the physicians will support Vascepa drug by prescribing them to the patients.
Amarin intends to submit sNDA to the FDA in the first quarter of 2019 seeking approval to expand the label of Vascepa and plans for a standard review with potential approval anticipated in late 2019. Amarin also intends to hire and train 400 sales reps in 2019 to promote Vascepa in the US.
Amarin shares pump up on positive results from cardiovascular study
Earlier this month, the company reported mixed results for the third quarter 2018, in which it beat analysts’ earnings estimates while missing the revenue targets. Amarin posted an adjusted loss per share of $0.06 on revenues of $55.3 million. The stock has jumped 280% so far in this year and 336% in the past 52 weeks.