- The Food and Drug Administration on Friday expanded the approval of Amarin's fish oil pill Vascepa, allowing the biotech to market the drug's heart benefit for a broad group of people at high risk of events like heart attack or stroke.
- While the New Jersey company received the widened approval it sought, the FDA's labeling for Vascepa's use is somewhat more restrictive than what Amarin had advocated. The FDA indicates Vascepa for treating patients whose triglyceride levels are elevated and who have either established cardiovascular disease or diabetes and additional risk factors.
- The approval is supported by an outcomes study known as REDUCE-IT, which found patients taking Vascepa on top of statin therapy were at a 25% lower risk of cardiovascular events compared to placebo. An expert panel convened last month by the FDA unanimously recommended the drug be cleared.
Results from REDUCE-IT have transformed Amarin from a company worth less than $1 billion to one now approaching $9 billion in market value.
The label expansion, which was expected following the positive advisory committee result, will trigger a boosted commercial effort around Vascepa (icosapent ethyl).
"We will be transitioning from a promotional effort that's largely been based upon a niche indication to triglyceride lowering, which is a biomarker-based indication, into an indication, assuming approval, that's for cardiovascular risk reduction," CEO John Thero said in a November interview with BioPharma Dive.
In order to do that, Amarin plans to expand its salesforce from 400 to 800 representatives and boost direct-to-consumer advertising.
In a Monday interview with BioPharma Dive, Thero said the doubled sales team will aim to reach 70,000 to 80,000 physicians in 2020, about 50% more than Amarin was planning for earlier this year. The chief executive also said he anticipates debuting new DTC advertising in mid-2020 after regulatory clearance.
Vascepa's current list price is about $300 for a 30-day supply for the 1-gram dose, and Thero has emphasized the company plans to grow sales through volume instead of pricing. The fish oil pill was first approved in 2012 for people with severe triglyceride levels.
Even before the formal label expansion, Vascepa sales and prescriptions have steadily grown since the REDUCE-IT data was presented, likely driven by off-label use. On Friday, the company released 2020 sales guidance for the first time, forecasting Vascepa sales of $650 million to $700 million.
While the label expansion is widely expected to grow Vascepa sales, Amarin had sought an even larger patient population than one the FDA eventually selected.
In documents submitted to the FDA's advisory committee, Amarin asked for a label covering primary prevention for adults at high risk of heart disease, but who don't yet have it. The company also proposed defining patients eligible for Vascepa as those with triglyceride levels of at least 135 mg/dL.
Instead, the actual label will require patients have triglyceride levels of at least 150 mg/dL and have a diagnosis of either cardiovascular disease or diabetes along with two or more other risk factors.
Still, Thero argued in the interview Vascepa’s label is "slightly broader" than the company was expecting, comparing it to the population studied in REDUCE-IT.
Either way, the expanded label covers millions of new potential patients and is a large reason why many on Wall Street see Amarin as a target for pharma companies looking to expand their cardiovascular offerings.
One potential buyer, the Swiss drugmaker Novartis, recently bought The Medicines Company for $9.7 billion, however, in an expensive bet on the biotech's would-be cholesterol drug.
Amarin still faces a legal challenge on Vascepa from several generic drugmakers, with a trial expected to start in January 2020. While the drug’s patents extend into 2030, the company settled last year with Teva Pharmaceutical to allow a generic competitor in August 2029.
"The nature of the pharmaceutical industry is any promising drug has challenges to its patents," Thero said Monday, adding Amarin will defend its intellectual property vigorously and declining to comment further.