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Glaxo Gets FDA Nod for Nucala for Hypereosinophilic Syndrome

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GlaxoSmithKline plc (GSK - Free Report) announced that the FDA has approved its drug, Nucala for a new indication hypereosinophilic syndrome (HES), a rare disease caused by eosinophilic inflammation.

Nucala, an anti-IL5 biologic, is presently marketed for eosinophil-driven diseases like severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. Also an eosinophil-driven disease, HES is the third indication for which it is now approved in the United States. Nucala is the first and only targeted biologic treatment to be approved for HES.

The FDA approval was based on positive data from a pivotal phase III study, which showed that when given Nucala, 50% fewer patients experienced a HES flare, over the 32-week study period, compared to placebo when added to standard-of-care treatment. HES patients suffer from debilitating flares and reducing them is the treatment goal of such medicines.

So far this year, Glaxo’s shares have declined 19.5% compared with the industry’s 1% decline.



Nucala is a key drug in Glaxo’s portfolio of new respiratory drugs. The drug’s sales of £451 million in first half of 2020 registered around 28% growth at constant exchange rate. Nucala is being evaluated in a late-stage study for COPD. Meanwhile, Glaxo expects to file regulatory submissions seeking approval of Nucala for chronic rhinosinusitis with nasal polyps (CRSwNP) indication this year

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

However, competitive pressure in the overall respiratory market has intensified with the launch of Regeneron (REGN - Free Report) and Sanofi’s (SNY - Free Report) blockbuster medicine, Dupixent and AstraZeneca’s (AZN - Free Report) Fasenra. Dupixent now is approved in the United States and the EU for three type II inflammatory diseases, namely CRSwNP, severe asthma and moderate-to-severe atopic dermatitis. Fasenra is approved for severe eosinophilic asthma while being studied for HES and CRSwNP.

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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