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GlaxoSmithKline GSK announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending approval of its drug, Nucala (mepolizumab), for three additional eosinophil-driven diseases.
While Nucala, an anti-IL5 biologic, is already approved for treating severe eosinophilic asthma in Europe, Glaxo is seeking approval of the drug for hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA), and chronic rhinosinusitis with nasal polyps (CRSwNP). If approved for these three indications, Nucala will be the only medicine in Europe approved for four eosinophil-driven diseases, which are inflammatory conditions associated with elevated levels of eosinophils, a type of white blood cell.
In the United States and some other countries, Nucala is already approved for the four eosinophil-driven diseases.
So far this year, Glaxo’s shares have risen 5.8% compared with the industry’s 8.5% increase.
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Nucala is a key drug in Glaxo’s portfolio of new respiratory drugs. The drug’s sales of £546 million in first half of 2021 registered around 29% growth at a constant exchange rate. Potential approval for additional indications in Europe can strengthen the drug’s eligible patient population and boost sales in the future. Nucala is presently being evaluated in late-stage studies for COPD.
However, competitive pressure in the overall respiratory market has intensified with the launch of Regeneron REGN and Sanofi’s SNY blockbuster medicine, Dupixent, and AstraZeneca’s AZN Fasenra. Dupixent 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 and is being studied for CRSwNP and COPD.
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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