Drugs

FDA Accepts Re-filed NDA for Acromegaly Drug

FDA has accepted for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with acromegaly. According to Chiasma, acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, which leads to significant health problems and early death if untreated. There are about 69,000 individuals with acromegaly worldwide. The agency set a 6/26 user fee review action target date.

In 2016, FDA sent Chiasma a complete response letter on the original submission. It said the submission had not provided substantial evidence of efficacy to warrant approval and that another clinical trial was needed in order to overcome this deficiency. It also expressed concerns regarding certain aspects of the company’s single-arm, open-label Phase 3 clinical trial and strongly recommended that the company conduct a randomized, double-blind and controlled trial that enrolled patients from the U.S. “and be of sufficiently long duration to ensure that control of disease activity is stable at the time point selected for the primary efficacy assessment,” the company said at the time.

The company says the resubmission includes data from the company’s recent CHIASMA OPTIMAL Phase 3 clinical trial. Prior to beginning that trial, Chiasma says it reached agreement with FDA on its design through a special protocol assessment.

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