GlaxoSmithKline plc (GSK - Free Report) announced positive data from a pivotal phase III study, which evaluated its asthma drug Nucala (mepolizumab) for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
A chronic inflammatory disease, CRSwNP leads to growth of soft tissue known as nasal polyps in the upper nasal cavities, causing nasal obstruction, loss of smell, facial pain and other problems. The SYNAPSE phase III study compared liquid formulation of Nucala added to standard of care (SOC) compared to placebo plus SOC in CRSwNP patients, all of whom had a history of previous surgery and required further surgery due to severe symptoms and increased size of their polyps.
Data from the study showed that Nucala can reduce symptoms and need for surgery in such patients. The study met both its co-primary endpoints. The data showed that the Nucala arm led to statistically significant improvement in both the size of nasal polyps at week 52 and in nasal obstruction during weeks 49-52 compared to the placebo arm.
Based on the favorable pivotal study data, Glaxo expects to file regulatory submissions seeking approval of Nucala for the CRSwNP indication this year
So far this year, Glaxo’s shares have declined 20.9% compared with the industry’s 10.5% decline.
Nucala, an anti-IL5 biologic, is presently marketed for eosinophil-driven diseases like severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. Nucala is also being evaluated in a late-stage study for COPD while regulatory submissions for Hypereosinophilic Syndrome, a rare inflammatory disorder, are expected to be filed this year.
Nucala is a key drug in Glaxo’s portfolio of new respiratory drugs. The drug’s sales of $768.0 million in 2019 registered around 33% growth at constant exchange rate.
Potential approval for additional indications can strengthen the drug’s eligible patient population and boost sales in the future.
Please note that Regeneron (REGN - Free Report) and Sanofi’s (SNY - Free Report) blockbuster medicine, Dupixent was approved by the FDA in June last year to treat CRSwNP in adults, whose disease is not controlled. In fact, competitive pressure in the overall respiratory market has intensified with the launch of Dupixent and AstraZeneca’s (AZN - Free Report) Fasenra
Glaxo currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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