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2020-04-05| Trials & Approvals

GSK Reports Positive Results for Nucala in Patients with Nasal Polyps

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Affecting one in seven adults in the U.S., Chronic rhinosinusitis can immensely downgrade patient’s quality of life. This long-lasting condition, which is mostly caused by infection or exposure to allergens is characterized by nasal obstruction, nasal congestion, continuous drainage of the nose, loss of smell and taste along with facial pain and pressure. It has been observed that some chronic rhinosinusitis patients go on to develop additional symptoms like nasal polyps, which is a soft tissue growth of the upper nasal cavity characterized by elevated levels of eosinophils.

 

Treatment for Chronic Rhinosinusitis with Nasal Polyps

Nasal polyps can be difficult to manage and reoccur even after surgical removal. Before Sanofi’s anti-inflammatory dual inhibitor Dupixent, the first FDA approved drug for this condition, the only way of suppressing nasal inflammation was by using intranasal corticosteroids and or, in severe cases intermittent courses of oral corticosteroids indicating an urgent need of medication in this area.

GlaxoSmithKline came out with the FDA approved drug Nucala (Mepolizumab) in 2015 for the treatment of eosinophilic asthma. Mepolizumab is a humanized monoclonal antibody that works by blocking the action of interleukin-5, thereby suppressing eosinophil count. After the FDA approval for the treatment of eosinophilic asthma in young children and adults, it was expanded for treatment of a rare autoimmune disorder eosinophilic granulomatosis with polyangiitis in 2017. By 2018, the drug was FDA approved in 22 markets including the U.S. and Europe for severe asthma.

With the success of the drug in inflammatory conditions, GSK now plans to expand the drug use for the treatment of another inflammatory indication, chronic rhinosinusitis with nasal polyps (CRSwNP). On Friday, the company announced that the SYNAPSE study evaluating Nucala in patients suffering from CRSwNP met both co-primary endpoints of reduction in the size of nasal polyps and nasal obstruction as well secondary endpoint of time to first surgery after treatment at week 52 compared to placebo. This is the first study that evaluated the benefits of biologic treatment in patients with a history of previous surgery and recurrent nasal polyps. Based on these data, GSK plans to file regulatory submissions in 2020. If approved, this will be the second drug to get FDA approval for treating CRSwNP after Dupixent.

Dr. Hal Barron, Chief Scientific Officer, and President R&D, GSK, said: “Nasal polyps are a common condition impacting many activities that most people take for granted, such as sleeping, breathing and having a sense of smell and taste. These results show that Nucala can reduce symptoms and need for surgery in patients with nasal polyps, and we look forward to progressing this regulatory submission.”

 

About the Phase III SYNAPSE Study

Nucala’s safety and efficacy were evaluated in a randomized, double-blind, parallel-group in comparison to the standard of care that ran for 52 weeks. The study enrolled over 400 adult patients with recurrent severe bilateral nasal polyps who were administered 100 mg of the drug along with the standard of care every 4 weeks for 52 weeks.

Claus Bachert, MD, Professor and Chief of Clinics ENT Department at Ghent University said: “The impact of CRSwNP on patients is substantial, but often underestimated. Treatment options are currently limited. These results show mepolizumab represents a promising alternative for patients who are caught in a cycle of surgeries. Each surgery carries risks and can disable the patient for several weeks.”

Related Article: GSK’s Trelegy Ellipta, an Advanced Treatment for Asthma & COPD Submitted for EU Approval

References
  1. https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-is-the-first-anti-il5-biologic-to-report-positive-phase-3-results-in-patients-with-nasal-polyps/
  2. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-rhinosinusitis-nasal-polyps
  3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.pdf
  4. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf

 

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