Speed, your letter is an excellent presentation for the powers that be at the FDA. It argues a very legitimate case for Vascepa. I hope you don't mind my suggestions (below) for a few minor editorial adjustments.
As a side note, I'm under treatment for ideopathic cardiomyopathy since 2002. I've had gastro problems for most of my life and feel like a lifelong adherent to proton pump inhibitors. Bowel symptoms have remained prevalent as well. Four years ago and again two years ago, I was hospitalized under emergency with ischemic colitis, first for nine days and next for ten days. Treatment with intravenous CIPRO and FLAGYL and DILAUDID for pain was successful in suppressing the infection. Each time I avoided re-sectioning of the colon. I always thought my heart would eventually kill me but never anticipated it would take this course....it's pretty scary.
My point in all this is that several years ago, I began learning about Vascepa as a TG lowering substitute, Lovaza was always difficult for me to take with awful eructation and bouts of dyspepsia. But over time, I began to understand the anti-inflammatory properties of EPA as well, so when Vascepa was approved, I bullied my Cardiologist into prescribing it for me. Here's the good part.....since initiating treatment in March, the frequency and severity of many of my bowel symptoms has decreased significantly. Random bouts of stomach and intestinal distress have lessened dramatically. Most importantly, my fear of dragging myself to the ER with the prospect of never leaving is beginning to wain....a little. I'm not calling it a miracle....but I do believe Vascepa is the agent at work. Maybe it can help some of your patients.
Your Letter:
"I am an academic center based gastroenterologist who specializes in both clinical practice and research related to obesity and inflammatory complications. With our current epidemic of obesityxxxxxxxxx, cardiovascular disease (CVD) remains the number one cause of adult mortality in the US. Although statins have had a major impact in improving CV outcome, risk of CVD remains high for many patients despite being on statin therapy. Previous studies have shown that elevated triglycerides (TG) are an important independent risk factor for CVD and that patients with elevated TG are much more likely to have complications related to CVD. Current recommendations of major medical societies including American Heart Association (AHA) and American Association of Clinical Endocrinologists (AACE) are to treat elevated TG levels above 200 mg/dl. The most recent guidelines published by the AACE in 2012 xxxxxxx state that “increasing clinical evidence suggests that elevated triglycerides may be an independent risk factor for CAD; therefore, AACE recommends screening of triglycerides as a component of lipid screening” and target “ triglyceride levels less than 150 mg/dL in both men and women are recommended (Grade A)”. Both AHA and AACE recommend treating triglyceride levels of 200-500 mg/dl with TG lowering agents “including omega fatty acids”. The current standard of care management strategy dictates that high risk patients with elevated triglycerides (200-500 mg/dl) be treated with TG lowering therapy.
Recently completed clinical trials (Marine and Anchor) have shown icosapent ethyl or vascepa to be highly efficacious in lowering TG in high risk patients with TG levels above 200 and 500 mg/dl without raising LDL-cholesterol levels. Moreover, the safety profile was excellent and favorable to other currently approved agents for lowering TG. Based on the published clinical trial data, vascepa has important therapeutic advantages over other currently approved medications for management of elevated TG levels in both safety and efficacy. Given the current recommendations by the major medical societies and the compelling data showing TG to be an independent risk factor for CVD, I urge the FDA to approve vascepa for treatment of TG between 200-500 mg/dl as the best drug in this class (best safety profile without raising LDL-cholesterol).
I would also like to express concern about the recent controversy surrounding the FDA advisory panel vote on the Amarin sNDA submission and the possible FDA decision to break the special protocol agreement (SPA) with Amarin. Amarin has fulfilled all aspects of the SPA in regards to the Anchor indication and sNDA submission. However, based on the xxxx voting question presented and comments made, the FDA seems poised to breach the SPA by imposing a new requirement before granting sNDA approval. If indeed this is being considered, it would be a huge mistake for the FDA as such action could materially damage FDA’s credibility going forward. In my view, this breach and violation of the SPA will have serious long-term consequences and could discourage new innovation and high risk development of drugs by small biotech companies. The suggestion by the FDA that “a substantial scientific issue essential to determining safety or efficacy of the drug has been identified after the testing has begun” is highly subjective and certainly has not been shown to be the case. The threshold level for such determination should be set xxxx very high xxxxx and any benefit of doubt should favor complying with the agreement. There were no substantive or indisputable evidence xxxxxxxxxx presented that demonstrate vascepa reduction of TG would fail to improve clinical outcome. All of the studies presented had major flaws in the design or did not study the high TG population. The only study to use icosapent ethyl showed a 53 % reduction in CVD related outcome, supporting the vascepa approval. In fact, more recent publications showing genetic linkage studies provide compelling evidence that elevated TG levels are an important risk factor of CVD.
In conclusion, TG elevation is an important risk factor for CVD and the current standard of care is to treat high risk patients with elevated TGs (200-500 mg/dl). Based on the clinical trial results of Anchor, which fulfilled all of the requirements of the SPA, I strongly urge the FDA to approve the sNDA for vascepas use in treating patients with elevated triglyceride levels between 200-500 mg/dl."
