Drugs

Insmed sNDA Gets Priority Review for Arikayce Full Approval

FDA has accepted for priority review an Insmed supplemental NDA seeking traditional approval for Arikayce (amikacin liposome inhalation suspension) for treating Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen. The agency has set a user fee review action target date of 1/28/2027.

Arikayce received FDA accelerated approval in 2018 for refractory MAC lung disease and was the first product approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs — a pathway established under the 21st Century Cures Act to advance the development of antibacterial therapies for serious or life-threatening infections in patients with unmet needs. “If full approval is granted, Arikayce could reach patients earlier in their disease course, including those newly diagnosed or facing recurrent infections,” the company says.

The sNDA for full approval is based on data from the Phase 3b ENCORE study, a pivotal study conducted to fulfill the post-marketing requirement associated with Arikayce's accelerated approval. “ENCORE met its primary endpoint and multiplicity-controlled secondary culture conversion endpoints, with Arikayce plus multidrug therapy demonstrating statistically significant improvements in respiratory symptoms and culture conversion in adults with MAC lung disease compared to multidrug therapy alone,” the company 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