Drugs

FDA Extends Review of Calliditas Therapeutics NDA

FDA has extended by three months the review of a Calliditas Therapeutics NDA seeking accelerated approval for Nefecon (budesonide) for treating primary IgA nephropathy (IgAN). The major amendment extension was ordered to provide the agency more time to review additional analyses of the company’s NeflgArd trial data which was requested by FDA. “The amendment mainly provides additional eGFR [estimated glomerular filtration rate] and other related analyses as further support of the proteinuria data provided in the NDA submission,” Calliditas says. The extended user fee review action target date is 12/15.

IgAN occurs when IgA protein gets stuck in the kidneys and causes inflammation. This can cause the kidneys to leak blood and protein, which can cause the kidneys to lose function and lead to kidney failure.

Nefecon is described as a patented oral formulation of budesonide for targeted release. “The formulation is designed to deliver the drug to the Peyer’s patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models,” the company says, adding that the drug can pass through the stomach and intestine without being absorbed, and then released in a “pulse-like fashion only when it reaches the lower small intestine.”

The NDA, which seeks accelerated approval, is based on positive data from Part A of the NefIgArd pivotal Phase 3 study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN, according to the company. “As previously reported, the study achieved its primary endpoint of proteinuria reduction compared to placebo, as well as showing stabilization of eGFR at nine months,” it says.

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