Drugs

FDA Refusing to Approve ITCA 650

FDA says CDER is proposing to refuse to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (exenatide in DUROS device), a drug/device combination product intended to deliver exenatide, a GLP-1 receptor agonist, as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. The notice says two CDER complete response letters identified these deficiencies in the NDA:

the clinical trial data demonstrated that the product causes acute kidney injury;
the cardiovascular risk assessment failed to provide sufficient assurance that ITCA 650 is not associated with excess cardiovascular risk;
the data provided to validate the limits of the in vitro dose delivery specifications did not support the safe and effective use of the device constituent in the product;
the data provided, inclusive of delivery performance data and failure analyses, did not demonstrate adequate device reliability associated with in vitro dose delivery to support safety and effectiveness for the intended use;
the information provided was inadequate in support of sterility assurance for ITCA 650; and
an FDA inspection of the Intarcia manufacturing facility identified deficiencies in the manufacturing practices for ITCA 650 that were not adequately addressed.

Intarcia has submitted several formal dispute resolution requests, the agency says, and each has been denied. It has requested an opportunity for a hearing and the notice gives the procedure to be followed to request a hearing before the FDA commissioner. The notice says the commissioner will grant a hearing if there exists “a genuine and substantial issue of fact or the commissioner concludes that a hearing would otherwise be in the public interest.”

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