Biologics

Argenx Plans sBLA for Vyvgart in Myasthenia Gravis

Argenx says it will file a supplemental BLA for Vyvgart (efgartigimod alfa-fcab) to expand its label to include adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG) after reporting positive topline results from a Phase 3 trial of patients in this patient population. The company says the submission will seek approval for use in three subtypes : MuSK-positive, LRP4-positive, and triple seronegative.

The ADAPT SERON study met its primary endpoint, with patients receiving Vyvgart showing a statistically significant and clinically meaningful improvement in the Myasthenia Gravis Activities of Daily Living total score compared to placebo, according to Argenx. “The results of the ADAPT SERON study, the largest to date in AChR-Ab seronegative gMG, confirm that Vyvgart now has the potential to be a targeted, effective, safe, and necessary treatment for patients living with gMG, regardless of autoantibody status,” it adds.

Vyvgart was well tolerated across all patient subtypes, with a safety profile consistent with previous studies in seropositive gMG and other indications, Argenx says, adding that no new safety concerns were identified.

The company says gMG is a rare, chronic autoimmune neuromuscular disease that causes fluctuating muscle weakness and fatigue. While about 80% of patients test positive for AChR antibodies, the remaining 20% are considered seronegative. Within this group, some patients test positive for other autoantibodies, such as MuSK or LRP4, while approximately 10% are “triple seronegative,” lacking detectable antibodies altogether, it 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