Amarin (AMRN) is having good fortune, especially when it comes to its supplemental new drug application (sNDA) for its drug Vascepa. That's because the biotech is seeking to expand the label for approval of its drug to reduce cardiovascular risk for patients with statin-managed LDL-C cholesterol (bad cholesterol), but with elevated levels of triglycerides. It was able to get the FDA to give priority review for its expanded label of Vascepa. This expanded label would be good news for the company and for patients who are at high risk of cardiovascular disease.
Priority Review Status Could Mean Quicker Approval Timetable
With the priority review status for the sNDA for Vascepa, this means that an FDA decision could come by September 28, 2019. There are several reasons why this approval is very much needed for Amarin. The obvious one is that it will allow the company to expand its label and generate more sales. In anticipation of getting a speedy review, the company has already chosen to expand its commercial operations to account for a potential increase of sales. The final reason and probably the most important one is improvement for patients' lives. According to the World Health Organization, cardiovascular disease is the number one cause of death for patients globally. About 17.9 million or 31% of deaths worldwide are due to cardiovascular disease. You can see why this is an important opportunity for patients and for Amarin as well. How does this happen exactly? Some cholesterol is good, but an unhealthy diet and other factors like obesity cause high levels of bad cholesterol and elevated levels of triglycerides (type of fat found in the blood). Having both of these issues puts patients at higher risk for cardiovascular disease. Most people when thinking about cardiovascular disease brush it off as not being serious. However, here are the outcomes of what can happen when a person has cardiovascular disease:
- Heart attack
- Heart disease
- Heart failure
- Arrhythmia (abnormal heart rhythm)
- Heart valve issue
There are some factors that a person can do to help against this disease like exercise, lose weight, and eat a healthier diet. All are good factors to help reduce cholesterol and triglycerides. However, doctors prescribe Vascepa to help keep bad cholesterol and triglycerides under control and to potentially lower them. The expanded label is to place an emphasis that patients treated with Vascepa might lower their risk of obtaining cardiovascular disease. Think about what this label could do to help improve sales of Vascepa. The ability to reduce the chance for someone to get one of the 6 problems noted above dealing with cardiovascular disease should be welcomed by both patients and Doctors. Specifically, Amarin will be targeting patients with residual cardiovascular disease after being stabilized on statin therapy.
REDUCE-IT Study Makes Case For Priority Review
Amarin obtaining Priority Review for its sNDA is good news. However, it wasn't given by the FDA on a whim. In order for the FDA to hand out Priority Review, they have to see that the treatment offers an improvement over other available therapies on the market. In essence, a drug that can achieve superior outcomes for patients that desperately need a new treatment option. Especially, when you consider that this sNDA of Vascepa holds the potential to impact the lives of more than 1 million patients. The reduction of risk for cardiovascular disease was shown when Amarin released results from its large REDUCE-IT study. Vascepa was able to meet the primary endpoint for this study, in that it achieved a 25% risk reduction in the first occurrence of MACE or Major adverse cardiovascular event compared to placebo. This reduction compared to placebo was statistically significant with a p-value of p<0.001. Even the secondary endpoint was able to achieve a 26% risk reduction in the 3-point MACE measure. This 3-point MACE measure included: Cardiovascular death, nonfatal heart attack and nonfatal stroke. As I highlighted above, those with bad cholesterol and elevated levels of triglycerides are at high risk for these events. The ability for Vascepa to not only help reduce bad cholesterol and triglycerides but to also provide a risk reduction in cardiovascular disease is quite amazing.
The sNDA for Vascepa being accepted by the FDA for Priority Review is very good news for the biotech. Especially, because the PDUFA date has been set 4 months earlier than expected to September 28, 2019. There are a couple of risk factors to keep in mind. While I believe the FDA will approve the sNDA for Vascepa, things in the biotech world are shaky. Especially, when it comes to the FDA because of its ever evolving changing on certain stances. That means there is no guarantee with certainty that the label for Vascepa will be expanded. In that case, the stock could crash possibly by 30% or more. That's because Amarin traded higher on the back of positive results from REDUCE-IT that its label for Vascepa could be expanded. If that were not to come to fruition, then investors may quickly head for the exit. The other risk I would consider is that sales of Vascepa may not end up increasing despite the new label. I'm inclined to believe that doctors would prefer to prescribe the drug more, because a 25% risk reduction in MACE is ideal for millions of patients. I think the Priority Review is a good sign for expanded approval.
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers deep dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.
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