Pharma Pulse: Amgen's Uplizna Secures CD19 Approval for Myasthenia Gravis, as Asthma Biologic Switches Highlight Efficacy Expectations Gap

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and let’s get into today’s headlines.

• Our first story focuses on the real-world management of severe asthma. New data published in Annals of Allergy, Asthma & Immunology reveals a significant challenge for biologic therapies: patient persistence. The study found that while most patients stick with their initial biologic, over half of those who do switch treatments do so because of a perceived lack of efficacy.This is a critical insight for manufacturers and prescribers. While agents like dupilumab and tezepelumab showed strong persistence, the need for switching highlights potential gaps—not just in clinical response, but in patient education and expectation setting.
• Now for a major regulatory breakthrough in rare diseases. The FDA has granted approval to Amgen’s Uplizna—or inebilizumab-cdon—for the treatment of adults with generalized myasthenia gravis, specifically those who are anti-acetylcholine receptor or anti-muscle specific kinase antibody positive. This is big news for the neuromuscular community. Uplizna is the first and only CD19-targeted B-cell therapy approved for gMG, representing a truly novel mechanism of action in this space. Crucially, the approval—supported by the Phase III MINT trial—allows for a highly convenient dosing schedule: patients receive maintenance doses just twice a year, offering six months of treatment-free time between infusions. This durable, less-frequent dosing is a major competitive differentiator in a crowded market and offers patients a significant quality-of-life benefit.

That’s it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access and care delivery, visit pharmaceuticalcommerce.com.

Thanks for listening—until next time, stay well and stay informed.

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