Drugs

Recognize Auryxia Regulatory Exclusivity: Keryx Petition

Keryx Biopharmaceuticals is asking FDA to recognize regulatory exclusivity for its Auryxia (ferric citrate) oral tablets containing “a novel mixture of covalent metal-ion complexes as its active moiety.” The company’s petition says that although the agency approved Auryxia nearly four years ago, it still has not made a determination about whether it should receive new chemical entity (NCE) exclusivity. And, the petition says, FDA also has not stated that Auryxia received three-year exclusivity for a new indication, even though the indication was supported with new clinical data.

The petition asks that FDA:

recognize that Auryxia earned five-year NCE exclusivity based on its novel active moiety;
recognize that Auryxia earned three years of exclusivity based on the approval of a new indication in 2017 for treating iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease;
require that ANDAs referencing Auryxia be supported with (1) comparative physio-chemical data demonstrating active pharmaceutical ingredient (API) sameness with Auryxia based on a qualitative and quantitative match regarding major ions and counterions and (2) in vivo bioequivalence data to address the drug’s systemic effects; and
revise the agency’s product-specific guidance about ferric citrate oral tablets to recommend that bioequivalence be established with an in vivo study and that API sameness be established based on a qualitative and quantitative match with regard to the major ions and counterions.

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