2024-11-08 08:44:00
AstraZeneca obtains new marketing authorization for Fasenra
Already approved as a basic treatment for severe uncontrolled eosinophilic asthma, AstraZeneca’s Fasenra (benralizumab) has just been authorized as an additional treatment for relapsed or refractory forms of eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is an autoimmune disease that manifests itself by eosinophilic inflammation that can affect all organs. In a phase III study, Fasenra demonstrated comparable efficacy to the only biologic treatment currently approved in Europe for EGPA, mepolizumab.
Novo Nordisk obtains positive phase III results
Novo Nordisk’s flagship GLP-1 drug semaglutide has obtained new positive results. In a pivotal phase III trial, it thus made it possible to improve liver fibrosis without worsening of steatohepatitis, as well as to resolve steatohepatitis without worsening of liver fibrosis in patients with steatohepatitis associated with metabolic dysfunction (MASH) and moderate to advanced liver fibrosis (stage 2 or 3). Novo plans to submit approval files to US and European regulators during the first half of 2025.
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Sanofi’s trivalent form of Efluelda flu vaccine authorized
Approved in more than 20 countries in its quadrivalent form, Efluelda, Sanofi’s influenza vaccine, has obtained marketing authorization for its trivalent version. In accordance with a recent recommendation from the WHO, which no longer deems the use of quadrivalent influenza vaccines necessary, the B/Yamagata strain having disappeared, Sanofi hopes for the return of trivalent Efluelda in France from the 2025-2026 vaccination campaign against the flu, which causes an average of 10,000 deaths each winter in France.
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**Interview with Dr. Emma Lawson, Hepatologist and Clinical Researcher**
**Interviewer:** Good morning, Dr. Lawson! Thank you for joining us today.
**Dr. Lawson:** Good morning, and thank you for having me.
**Interviewer:** We just learned about Novo Nordisk’s GLP-1 drug semaglutide showing promising results in treating patients with liver fibrosis associated with metabolic dysfunction. Can you tell us what these results might mean for patients with liver conditions?
**Dr. Lawson:** Absolutely. The results from the phase III trial are quite encouraging. A 37% improvement in liver fibrosis among patients treated with semaglutide is significant, as it suggests that the drug could provide a new treatment option for those suffering from conditions like metabolic dysfunction-associated steatotic liver disease (MASH).
**Interviewer:** You mentioned MASH—how does liver fibrosis develop in patients with this condition?
**Dr. Lawson:** MASH is characterized by fat accumulation in the liver, and over time, this can lead to inflammation and liver damage, culminating in fibrosis. The underlying metabolic issues, such as obesity and diabetes, exacerbate this process. Reducing liver fibrosis is crucial because it can lead to cirrhosis and increase the risk of liver cancer.
**Interviewer:** Given these findings, what are Novo Nordisk’s next steps regarding semaglutide?
**Dr. Lawson:** Novo Nordisk plans to submit approval files to both US and European regulators in the first half of 2025. If approved, this could change the landscape of treatment options for patients with liver fibrosis associated with MASH, as there are currently limited therapies available.
**Interviewer:** That sounds promising. How do you see the integration of drugs like semaglutide into current treatment protocols?
**Dr. Lawson:** Integrating semaglutide into treatment protocols could shift how we approach liver disease management. It provides clinicians with a powerful tool not only to address the metabolic aspects of liver disease but also to potentially reverse some of the damage that has already been done. It emphasizes the importance of a comprehensive approach that includes lifestyle changes alongside pharmacotherapy.
**Interviewer:** Thank you, Dr. Lawson. It’s exciting to think about the potential advancements in treatment for these challenging liver conditions.
**Dr. Lawson:** Thank you for having me. I look forward to more developments in this field!