DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA – approximately 465 mg) and docosahexaenoic acid (DHA – approximately 375 mg).
The structural formula of EPA ethyl ester is:
The empirical formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51.
The structural formula of DHA ethyl ester is:
The empirical formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55.
LOVAZA capsules also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of partially hydrogenated vegetable oils including soybean oil), and gelatin, glycerol, and purified water (components of the capsule shell).
Lovaza
A US appeals court ruled on this week that drug companies can develop generic versions of fish oil-derived, high-cholesterol drug Lovaza.
read all at
Lovaza is a brand name prescription drug. The capsule sold by GlaxoSmithKline but developed by Reliant Pharmaceuticals, contains esterified fish oils and is approved by the U.S. Food and Drug Administration to lower very high triglyceride levels. It is metabolized intoOmega-3 fatty acids. It is a dietary supplement that has been purified, chemically altered, branded, and been put through the approval process of the U.S. Food and Drug Administration (FDA); in these respects it is considered a pharmaceutical. Due to the esterification process during manufacturing there is no risk of contamination[citation needed] by methyl mercury, arsenic,[1] or other pollutants that are often seen in the world’s oceans. Each 1-gram capsule is 38% DHA, 47% EPA, and 17% other fish oils in the form of the ethyl ester.
Lovaza is named Omacor in Europe (and this name was once used in the US).[2]
Effectiveness
Lovaza is approved in the U.S. for treatment of patients with very high triglycerides (hypertriglyceridemia).[3]
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 been demonstrated to reduce triglycerides in patients with high or very high triglycerides. [3]
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%.[4] 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 elevatealanine transaminase levels, so liver enzymes should be checked, periodically.[4]
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 (this is in the US; however, data from GISSI-P showed a combined end-point of all-cause death, non-fatal MI, and non-fatal stroke was significantly reduced by 15%). 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.[3]
GlaxoSmithKline‘s patent expired in September 2012. Generic versions may be made available at that time. Other DHA/EPA products containing similar amounts of Omega-3 fatty acids are currently sold over the counter in the United States as dietary supplements.
Competitors
In July 2012, Amarin Corporation received U.S. FDA marketing approval for Vascepa, also referred to as AMR-101.[5] Vascepa will undoubtedly become a major competitor for Lovaza.[6] In clinicial 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.[7]
In 2011, Ariix started selling an almost identical FDA-Certified Omega3 Ethyl Ester 1000 mg capsule ‘OmegaQ’ fish oil through direct marketing and online auto-ship at a discounted price, creating another major competitor for Lovaza and Amarin’s Vascepa. One capsule contains 295 mg EPA, and 235 mg DHA, but it is unique in that it is combined with 20 mg of the coenzyme CoQ-10, with reported ‘anti-aging’ effects on the cell’s telomeres, which are still under study.
Forms of Lovaza
Lovaza is available as 1-gram soft-gelatin capsules.[8]
Active Ingredient: Omega-3-acid ethyl esters
Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in soybean oil)
References
- 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”
- “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.
- http://www.rxwiki.com/lovaza
New Drug Approvals 
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