Lovaza is a brand name prescription drug. The capsule sold by GlaxoSmithKline but developed by Reliant Pharmaceuticals, contains esterified fatty acid ethyl esters and is described in detail in US Patent 5,656,667. Pronova BioPharma is the innovator company for the APIs in Lovaza/Omacor. It is synthesized from fish body oils, typically from oily fish such as mackerel and anchovy. It is approved by the FDA (Food and Drug Administration) to lower very high triglyceride levels. It is a pro-drug that is metabolized into Omega-3 fatty acids and ethanol. It is not a dietary supplement and has been wrongly called "fish oil" which it is clearly not. It is a pharmaceutical drug with the two main active pharmaceutical ingredients (API) being EPA-ethyl ester and DHA-ethyl ester. After the esterification process, molecular distillation is used to decrease organic pollutants, methylmercury, arsenic, or other pollutants that are often seen in the world's oceans. Each capsule weighs (drug product) 1.43089 g and contains 0.99461 grams of liquid. This is composed of 465 mg EPA ethyl ester and 375 mg DHA ethyl ester. There is an additional approximately 130 mg of other omega-3 fatty acid ethyl esters.
Lovaza is named Omacor in Europe (and this name was once used in the US).
Lovaza is approved in the U.S. for treatment of patients with very high triglycerides (hypertriglyceridemia).
In the European markets and other major markets outside the US Lovaza is known as Omacor, and is indicated for:
- Hypertriglyceridemia. Used as monotherapy, or in combination with a statin for patients with mixed dyslipidemia.
- Secondary prevention after myocardial infarction (heart attack)
in addition to other standard therapy (e.g. statins, antiplatelets medicinal products, beta-blockers, and ACE-I).
Lovaza has also been demonstrated to reduce VLDL-cholesterol and non-HDL-cholesterol, and increase HDL-cholesterol. But, it can raise LDL-cholesterol up to 45%. The LDL raising activity correlates with a reduction in ApoB levels, though. Lovaza, through the stimulation of Lipoprotein Lipase, seems to stimulate the production of less atherogenic LDL species. In some patients, it can elevate alanine transaminase levels, so liver enzymes should be checked, periodically.
Effects on significant patient outcomes such as acute myocardial infarction, stroke, cardiovascular and all-cause mortality have been studied in patients who have suffered a myocardial infarction. Lovaza has not been shown to lower the rates of all cause mortality and cardiovascular mortality, or the combination of mortality and non-fatal cardiovascular events.
GlaxoSmithKline's patent expired in September 2012. Generic versions of Lovaza were introduced in America in April 2014. Other DHA/EPA products containing similar amounts of omega-3 acid ethyl esters that are currently sold over the counter in the United States as dietary supplements. These products also produce ethanol as a metabolite.
In July 2012, Amarin Corporation received U.S. FDA marketing approval for Vascepa, also referred to as AMR-101. Vascepa will undoubtedly become a major competitor for Lovaza. In clinical trials, Vascepa was shown to lower triglycerides; while Lovaza also lowers the triglyceride concentration, Vascepa also lowers LDL-C; Lovaza does not. Lovaza was approved to treat people with very high triglyceride levels (>500 mg/dl), Vascepa is also approved for this market; however the company has also demonstrated that the drug can impact levels in people with high triglyceride (> 200 mg/dl and < 500 mg/dl) levels and will file an sNDA for this indication late in 2012.
Forms of Lovaza
Lovaza is available as 1-gram soft-gelatin capsules.
Active Ingredient: Omega-3-acid ethyl esters
Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in soybean oil)
- NIFES (Nasjonalt institutt for ernærings- og sjømatforskning – Norwegian National Institute for Nutrition and Seafood Research)
- University of Utah Pharmacy Services (August 15, 2007) "Omega-3-acid Ethyl Esters Brand Name Changed from Omacor to Lovaza"
- GSK Information for Medical Professionals
- Pharmacy & Therapeutics (May, 2008) "Omega-3-acid Ethyl Esters (Lovaza) For Severe Hypertriglyceridemia"
- http://www.empr.com/teva-launches-generic-lovaza/article/342205/ Teva Launches Generic Lovaza
- "Amarin Prescription Fish-Oil Pill Approved - TheStreet". Retrieved 26 July 2012.
- "http://www.reuters.com/article/2012/07/26/us-amarin-fda-vascepa-idUSBRE86P1SX20120726". Reuters. 26 July 2012. Retrieved 27 July 2012.
- "Amarin's AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints with Statistically Significant Reductions in Triglycerides at Both 4 Gram and 2 Gram Doses and Statistically Significant Decrease in LDL-C (NASDAQ:AMRN)". Amarin. 18 April 2011. Retrieved 26 July 2012.