The FDA agreed with Amarin that Vascepa and a competing drug to combat trigylcerides in the bloodstream, Lovaza, have different active ingredients, yet the agency “refused to recognize five-year statutory exclusivity for Vascepa, ”the Dublin-based company said in a complaint filed today in Washington.
While the active ingredient in Vascepa, icosapent ethyl, a type of omega-3 fatty acid, is present in Lovaza, its active ingredient of Lovaza is an undifferentiated fish-oil mixture, according to the complaint. The mixture is not the same as Vascepa’s active ingredient (icosapent ethyl),’’ according to the complaint.
Under FDA precedent, prior approval of a drug whose active ingredient is a complex mixture doesn’t bar exclusivity for a drug that’s approved later “whose active ingredient is a constituent of that mixture ineligible for new chemical entity exclusivity,” Amarin argued in the suit.
Lovaza is marketed by GlaxoSmithKline Plc. (GSK)
Both drugs are approved for the use in treating very high levels of triglycerides, the blood fat that can lead to stroke and heart attack.
The FDA changed its standards for awarding market exclusivity and applied “its new approach retroactively to Vascepa,” according to Amarin’s suit. “Amarin should not be penalized because -- after Amarin developed and secured approval for Vascepa -- FDA has decided to adopt a new policy that conflicts with its past practice,” Amarin lawyers said in the filing.
Morgan Liscinsky, an FDA spokeswoman, said in an e-mail that the agency doesn’t comment on pending litigation.
In addition to battling over market exclusivity, Amarin is appealing an FDA requirement for more study of Vascepa in connection with an application to expand its use.
Expanding use of Vascepa, Amarin’s only product, to less seriously ill patients who have elevated triglycerides would give the drugmaker access to 36 million U.S. customers, or nine times the pool of people with very high levels.
Amarin is seeking to treat high triglyceride patients on statin therapy who have low levels of good cholesterol and coronary heart disease.
The case is Amarin v. FDA, 14-cv-00324, U.S. District Court, District of Columbia (Washington).
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