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Glaxo's Nucala Meets Goal in Rare Inflammatory Disorder Study

Zacks Equity Research

GlaxoSmithKline plc GSK announced positive data from a pivotal phase III study evaluating its asthma drug Nucala (mepolizumab) for another indication called Hypereosinophilic Syndrome (HES), a rare inflammatory disorder.

The study met the primary endpoint by demonstrating a statistically significant reduction in flares in patients with HES.

Data from the study showed that 50% fewer patients experienced a HES flare when treated with Nucala plus standard of care compared to patients who received placebo + standard of care treatment for a period of 32 weeks. All secondary endpoints were also met and no new safety signals were reported during the study.

This positive data makes Nucala the first treatment to demonstrate a reduction in flares for this rare inflammatory disease.

Based on such favorable results, Glaxo plans to submit a regulatory filing for Nucala in 2020 to treat HES.

Shares of Glaxo have rallied 16.9% so far this year compared with the industry’s rise of 3.6%.

We remind investors that Nucala is marketed in the United States and the EU for severe eosinophilic asthma.

Nucala is also approved for treating eosinophilic granulomatosis with polyangiitis and is in late-stage development for nasal polyps. Earlier this year, two new self-administered options for Nucala, an auto injector and a pre-filled safety syringe, to be taken once every four weeks, were approved in the United States and the EU.

Nucala is a key drug in Glaxo’s portfolio of new respiratory drugs. The drug’s sales of $707.2 million in the first nine months of 2019 registered around 35% growth at constant exchange rate.

Potential approval for additional indications can strengthen the drug’s eligible patient population and boost sales in the future.

However, competitive pressure in the respiratory market intensified with the launch of AstraZeneca’s AZN Fasenra and Sanofi SNY /Regeneron Pharmaceuticals’ REGN Dupixent.

Zacks Rank

Glaxo currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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