Drugs

FDA Gives Amarin 5-Year Exclusivity Under Court Remand

FDA has determined that Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) capsules are now eligible for five-year, new chemical entity marketing exclusivity under the Hatch-Waxman Amendments. The exclusivity period will run until 7/2017, and the statutory 30-month stay triggered by patent litigation following a generic application submission would expire on 1/2020, according to the company.

FDA’s determination is consistent with a 2015 federal court opinion that granted Amarin summary judgment in a case that challenged an earlier agency decision denying the company’s eligibility for five-year new chemical entity exclusivity for Vascepa. In that denial, FDA determined that eicosapentaenoic acid (EPA), the single active moiety in Vascepa, was also an active moiety contained in a previously approved drug, Lovaza (omega-3-acid ethyl esters).

In its complaint, Amarin contended that FDA had acknowledged that the “active ingredient in Lovaza is an undifferentiated fish oil mixture of which icosapent ethyl is only one of many constituents. Thus, FDA agreed with Amarin that Vascepa and Lovaza have different active ingredients. FDA nevertheless refused to recognize five-year statutory exclusivity for Vascepa on the grounds that Lovaza’s active ingredient is not also its ‘active moiety’ and that Vascepa and Lovaza share a common ‘active moiety.’”

In siding with the company, judge Randolph Moss was bothered by FDA’s insistence that the phrases “active ingredient” and “active moiety” are synonymous. “The FDA has offered no basis to justify its decision to construe the statute’s reference to an ‘active ingredient’ that ‘has been approved’ as referring to any ‘active moiety’ that the FDA might someday find is consistently present and responsible at least in part for the mixture’s pharmacological action,” the opinion said. He ordered the agency’s decision vacated and remanded the matter to FDA for proceedings consistent with his opinion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome