Drugs

Novartis to Seek Approval for Sjögren’s Disease Drug

Novartis says that it will seek FDA approval of its investigational drug ianalumab after it met the primary endpoint in two Phase 3 trials for Sjögren’s disease, a chronic autoimmune condition that can damage glands, skin, joints, kidneys, lungs, and other organs. Most patients experience dry eyes and mouth, along with fatigue and pain, according to the company, adding that there are currently no approved systemic treatments.

Novartis says the global NEPTUNUS-1 and NEPTUNUS-2 studies are the first Phase 3 trials to show a statistically significant reduction in disease activity for Sjögren’s. The drug works by both depleting B cells and blocking BAFF-R signaling, mechanisms thought to drive the disease. In both studies, patients receiving ianalumab had greater improvements on the EULAR Sjögren’s Syndrome Disease Activity Index compared to placebo. The company says the drug was well-tolerated and had a favorable safety profile.

Ianalumab is also being investigated for other autoimmune conditions, including systemic lupus erythematosus, lupus nephritis, immune thrombocytopenia, and diffuse cutaneous systemic sclerosis, according to Novartis.

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