Drugs

Tricida ‘Surprised’ at FDA Veverimer Comments

Tricida says it was surprised by comments made by representatives of the CDER Division of Cardiology and Nephrology at a 10/20 end-of-review conference on its investigational drug veverimer. The drug is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). A company statement said the meeting followed the company’s 8/21 receipt of a complete response letter for the veverimer NDA that the agency was reviewing under the accelerated approval program.

The company says it believes that FDA will require evidence of veverimer’s effect on CKD progression from a near-term analysis of the VALOR-CKD trial for approval under the accelerated approval program and is unlikely to rely solely on sodium bicarbonate data for determination of efficacy.

“The company’s ongoing VALOR-CKD trial was designed to be a confirmatory trial to demonstrate the effect of veverimer on slowing CKD progression following accelerated approval,” Tricida says. “Based on the primary endpoint and patient population in VALOR-CKD, Tricida does not believe it can provide information on CKD progression from a near-term interim analysis of the VALOR-CKD trial without compromising the integrity of the ongoing trial.”

Tricida says it continues to believe that its development program for veverimer is an appropriate candidate for accelerated approval and will wait to receive formal meeting minutes from FDA before determining how to proceed to obtain regulatory approval.

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