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Glaxo's (GSK) Nucala Filing for Nasal Polyps Accepted by FDA
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GlaxoSmithKline plc (GSK - Free Report) announced that the FDA accepted its regulatory filing seeking approval of its respiratory drug, Nucala (mepolizumab) for a new indication - chronic rhinosinusitis with nasal polyps (CRSwNP).
Nucala, an anti-IL5 biologic, is presently marketed for three eosinophil-driven diseases like severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (“EGPA”) and hypereosinophilic syndrome (“HES”). Also, an eosinophil-driven disease, CRSwNP, is the fourth indication for which Glaxo is seeking approval of the drug in the United States.
If approved, Nucala will be the first anti-IL5 biologic for CRSwNP and the only targeted biologic treatment for four eosinophil-driven diseases in the United States.
The regulatory submission for the CRSwNP indication was based on data from the pivotal SYNAPSE study which evaluated the effect of Nucala in more than 400 patients.
Shares of Glaxo have declined 19.9% so far this year against the industry’s increase of 2.9%.
Nucala is a key drug in Glaxo’s portfolio of respiratory drugs. Nucala generated sales worth £702 million in the first nine months of 2020, registering around 28% growth at constant exchange rate.
Meanwhile, Nucala is also being evaluated in a late-stage study for chronic obstructive pulmonary disease (COPD). Potential approval for additional indications can strengthen the drug’s eligible patient population and boost sales in future.
Notably, in October 2020, the European Commission accepted Glaxo’s regulatory filings seeking approval of Nucala for HES, CRSwNP and EGPA. The drug is already approved to treat severe eosinophilic asthma in the European Union.
We note that 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 is approved in the United States and the EU for specific patients with CRSwNP, severe asthma and moderate-to-severe atopic dermatitis. Fasenra is approved for severe eosinophilic asthma while being studied for HES and CRSwNP.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
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Glaxo's (GSK) Nucala Filing for Nasal Polyps Accepted by FDA
GlaxoSmithKline plc (GSK - Free Report) announced that the FDA accepted its regulatory filing seeking approval of its respiratory drug, Nucala (mepolizumab) for a new indication - chronic rhinosinusitis with nasal polyps (CRSwNP).
Nucala, an anti-IL5 biologic, is presently marketed for three eosinophil-driven diseases like severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (“EGPA”) and hypereosinophilic syndrome (“HES”). Also, an eosinophil-driven disease, CRSwNP, is the fourth indication for which Glaxo is seeking approval of the drug in the United States.
If approved, Nucala will be the first anti-IL5 biologic for CRSwNP and the only targeted biologic treatment for four eosinophil-driven diseases in the United States.
The regulatory submission for the CRSwNP indication was based on data from the pivotal SYNAPSE study which evaluated the effect of Nucala in more than 400 patients.
Shares of Glaxo have declined 19.9% so far this year against the industry’s increase of 2.9%.
Nucala is a key drug in Glaxo’s portfolio of respiratory drugs. Nucala generated sales worth £702 million in the first nine months of 2020, registering around 28% growth at constant exchange rate.
Meanwhile, Nucala is also being evaluated in a late-stage study for chronic obstructive pulmonary disease (COPD). Potential approval for additional indications can strengthen the drug’s eligible patient population and boost sales in future.
Notably, in October 2020, the European Commission accepted Glaxo’s regulatory filings seeking approval of Nucala for HES, CRSwNP and EGPA. The drug is already approved to treat severe eosinophilic asthma in the European Union.
We note that 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 is approved in the United States and the EU for specific patients with CRSwNP, severe asthma and moderate-to-severe atopic dermatitis. Fasenra is approved for severe eosinophilic asthma while being studied for HES and CRSwNP.
Zacks Rank
Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
Click here for the 6 trades >>