FDA Approves Three More Omega

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Three more omega-3 drugs are now on the heart health market. In the past two months, FDA approved AstraZeneca’s brand-name EPA/DHA drug Epanova, as well as two generics, all targeting hypertriglyceridemia (triglyceride levels equal to or higher than 500 mg/dL).

Lovaza (GlaxoSmithKline) was, until recently, the only EPA/DHA omega-3 brand-name drug on the market for hypertriglyceridemia. (One more brand-name hypertriglyceridemia omega-3 drug competes with Lovaza and Epanova—Vascepa (Amarin Pharma), which contains EPA fatty acids only.) FDA-approved in May, AstraZeneca’s Epanova (New Drug Application #205060) now goes head to head with Lovaza, and the two will compete on bioavailability claims. Lovaza’s EPA and DHA omega-3 fatty acids are esterified. Before the body can absorb the esters, it must first convert (de-esterify via molecule-cleaving) them into “free,” non-esterified form. Unlike Lovaza, Epanova’s EPA and DHA fatty acids are already in free form.

In April, FDA approved two generic omega-3 EPA/DHA drugs: Omtryg (NDA #204977) by Trygg Pharma AS (jointly owned by Aker BioMarine ASA and Lindsay Goldberg LLC) and a generic from Teva Pharmaceuticals (ANDA #091028). Like Lovaza—and unlike Epanova—these DHA/EPA generic drugs are in ester form.

All of these drugs will now contend for patients with hypertriglyceridemia—a condition in which triglycerides (a type of blood lipid) are too high, leading to complications such as high cholesterol and heart disease, as well as associated conditions like obesity and diabetes. According to AstraZeneca, which bought the rights to Epanova from Omthera Pharmaceuticals, nearly four million Americans suffer from severe hypertriglyceridemia, and this number is growing.

For the omega-3 supplements industry, what are the ramifications of a growing omega-3 pharma market? All of these firms—pharma and supplement—are fishing from the same supply pool, after all.

Harry Rice, PhD, vice president of scientific and regulatory affairs for the Global Organization for EPA and DHA Omega-3s (Salt Lake City, UT), says that the supplements industry stands to benefit from the consumer attention and research that drug companies will bring to omega-3s.

“While a finite supply of fish oil coupled with pharma companies willing to pay the highest premiums may be perceived as a threat to the fish oil dietary supplement industry, the upside is that the pharma companies are investing heavily in research and education. This will result in a more educated consumer, not only about cardiovascular health, but for other health indications,” he says.

Source: nutritional outlook

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