Drugs

Mallinckrodt ‘Complete Response’ on Terlipressin NDA

FDA has again issued Mallinckrodt a Complete Response Letter on its NDA for terlipressin to treat adults with hepatorenal syndrome (HRS), an acute and life-threatening condition involving rapid reduction in kidney function. “Within the last two weeks, it became necessary to identify a new packaging and labeling manufacturing facility which meant that an inspection of the new facility by the FDA could not be completed by the [user fee] date,” the company says. “This is the only outstanding issue noted in the CRL, and it is important to note that there were no safety or efficacy issues cited.” In 9/2020, the agency issued a CRL letter that said the NDA was not approvable in its current form and required more information to support a positive risk-benefit profile (see earlier story).

Mallinckrodt says it is working with the new facility to have it ready for inspection, adding that it believes that there is a path to approval in 2022.

Terlipressin is a potent vasopressin analog selective for V1 receptors, according to Mallinckrodt. It describes HRS-1 as an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. It has a median survival time of about two weeks and greater than 80% mortality within three months if left untreated, it says. It is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.

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