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Glaxo's Asthma Drug Gets EU Nod for Pediatric Population

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GlaxoSmithKline Plc. (GSK - Free Report) announced that the European Commission has given a marketing approval to its asthma drug Nucala for treating pediatric patients. Following the regulatory body’s decision, Nucala (mepolizumab) is now available as an add-on treatment for severe refractory eosinophilic asthma in both adult and paediatric patients in Europe.

The approval was expected as in July, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a nod for Nucala in the given indication.

Shares of Glaxo have returned 16.2% so far this year, outperforming the industry’s increase of 5.1%.

Following the approval, Nucala becomes the first and only approved biologic therapy for children aged from six to 17 years with severe asthma that targets interleukin-5 (IL-5).

Notably, in July, the FDA advisory committee recommended against approving the label expansion of Nucala for a new indication, chronic obstructive pulmonary disease (COPD). The committee suggested that the risk-benefit profile of Nucala, demonstrated in studies, was not adequate to support approval.

However, last December, the FDA approved the label expansion of Nucala to include treatment of eosinophilic granulomatosis with polyangiitis ("EGPA"). EGPA is a rare autoimmune disease, causing inflammation in small and medium-sized blood vessels. It can induce damage to lungs, sinuses, skin, heart, gastrointestinal tract, nerves and other organs.

Nucala along with Glaxo’s Ellipta products is one of the key revenue drivers for the company. Sales of the company’s new respiratory portfolio comprising Ellipta products and Nucala grew 27% in second-quarter of 2018. Nucala sales soared 100% in the reported quarter supported by its global rollout as well as market expansion in the United States. The sales of these new respiratory products are making up for the decline in sales of the older respiratory products.

Zacks Rank & Stocks to Consider

Glaxo currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks to consider in the biotech sector are Bristol-Myers Squibb Company (BMY - Free Report) , Gilead Sciences, Inc. (GILD - Free Report) and Eli Lilly and Company (LLY - Free Report) . While Bristol-Myers and Gilead sport a Zacks Rank #1 (Strong Buy), Eli Lilly carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings estimates have been raised 5% for 2018 and 4.9% for 2019 over the past 60 days.

Gilead Sciences’ earnings estimates have been moved 7.5% north for 2018 and 1.9% for 2019 over the past 60 days. The stock has gained 6.5% year to date.

Eli Lilly’s earnings estimates have been raised 6.2% for 2018 and 4% for 2019 over the past 60 days. The stock has rallied 24.9% year to date.

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