Drugs

FDA Advisors to Review FibroGen Roxadustat NDA

The FDA Cardiovascular and Renal Drug Advisory Committee will consider a FibroGen NDA for roxadustat to treat anemia of chronic kidney disease in both dialysis-dependent and non-dialysis-dependent patients on 7/15. The company says its NDA is supported by positive results from a global Phase 3 program covering more than 8,000 patients.

The company also issued a statement to clarify certain prior disclosures of U.S. primary cardiovascular safety analyses from the Phase 3 program. “As members of senior management were preparing for the upcoming FDA advisory committee meeting, we became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors,” said FibroGen CEO Enrique Conterno. “While all of the analyses … including the differences in the stratification factors were included in the NDA, we promptly decided to clarify this issue with FDA and communicate with the scientific and investment communities. It is important to emphasize that this does not impact our conclusion regarding the comparability, with respect to cardiovascular safety, of roxadustat to epoetin-alfa in dialysis-dependent patients and to placebo in non-dialysis dependent patients. We continue to have confidence in roxadustat’s benefit/risk profile.”

The statement says there is no change in the underlying Roxadustat data or to the efficacy analyses from the Phase 3 program.

Roxadustat is described as the first in a new class of medicines, HIF-PH inhibitors that promote erythropoiesis through increased endogenous production of erythropoietin and downregulation of hepcidin. It is also in clinical development, FibroGen says, for anemia associated with myelodysplastic syndromes and for chemotherapy-induced anemia.

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