Drugs

FDA Mulls Safety Signal on Intercept’s Ocaliva

Intercept Pharmaceuticals says FDA has told the company that it is evaluating a “newly identified safety signal regarding liver disorder for Ocaliva which the FDA classified as a potential risk.” The signal was noticed in May during the agency's routine safety surveillance, Intercept says in a financial report. In 2016, FDA granted accelerated approval for Ocaliva (obeticholic acid) for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA (see earlier story).

In July, FDA rejected an Ocaliva indication for treating NASH (nonalcoholic steatohepatitis). FDA had postponed two advisory committee meetings that were to consider the company’s NDA and then rejected the drug because agency staff were uncertain if the Phase 3 trial surrogate endpoint (reduction in liver fibrosis) would actually translate into benefit for patients. While the agency suggested the company resubmit with longer-term data from the Phase 3 trial, the newsletter says, Intercept complained about the agency decision.

In a statement, company CEO Mark Pruzanski criticized FDA for canceling the advisory committee meetings, said the agency review was incomplete, and accused FDA of repeatedly moving the goalposts for approval in a way that could prevent the development of new therapies.

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