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EMA Accepts GSK's Filing for Depemokimab in Two Respiratory Diseases
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GSK plc (GSK - Free Report) recently announced that EMA has accepted the regulatory filing seeking approval for its IL-5 inhibitor depemokimab in two respiratory indications – asthma with type II inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP).
With regard to the asthma indication, the GSK submission seeks approval for the drug in individuals aged 12 years and older. Concerning CRSwNP, GSK intends to secure approval in adults. Similar regulatory filings for the drug have also been validated for review in China and Japan.
If approved, depemokimab will be the first ultra-long-acting biologic that requires the administration of only one dose every six months.
The GSK drug is yet to be approved for use in any country.
GSK Stock Performance
Shares of GSK have lost 10% in the past year compared with the industry’s 11% decline.
Image Source: Zacks Investment Research
More on GSK’s Depemokimab Filings
GSK’s regulatory filings are supported by positive data from two late-stage programs – SWIFT and ANCHOR. While the SWIFT studies evaluated depemokimab in asthma indications, the ANCHOR studies assessed the drug for CRSwNP.
The SWIFT studies achieved their co-primary endpoints – treatment with depemokimab led to a statistically significant reduction in nasal polyp size and nasal obstruction compared to placebo plus standard of care at 52 weeks.
Depemokimab is designed to target IL-5, a key protein in type II inflammation. This inflammation pathway affects most patients with difficult-to-treat asthma, increasing the risk of exacerbations and hospitalization. It is also found in up to 80% of people with CRSwNP, leading to more severe symptoms and disease progression.
Apart from the above two indications, depemokimab is also being evaluated in late-stage studies for other IL-5-mediated diseases. These include the OCEAN studies for eosinophilic granulomatosis with polyangiitis (EGPA) and DESTINY studies in hypereosinophilic syndrome (HES) indication.
Other Players in the Respiratory Diseases Market
If approved, GSK’s depemokimab will face stiff competition from Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) blockbuster IL-4 and IL-13 inhibitor, Dupixent. This blockbuster SNY/REGN drug is currently approved in several countries (including the United States and EU) across multiple type II inflammatory diseases, which include asthma, COPD and CRSwNP.
In September, the FDA expanded Dupixent’s label in the CRSwNP indication for use in adolescent patients aged 12 to 17 years. The drug has already been approved to treat adults with the condition since 2019.
Besides Dupixent, the drug could also face strong competition from AstraZeneca’s (AZN - Free Report) Fasenra, also an IL-5 inhibitor. This AZN drug is currently approved for two indications, namely eosinophilic asthma and EGPA. AstraZeneca is also evaluating the drug in late-stage studies for COPD and HES indications.
Image: Bigstock
EMA Accepts GSK's Filing for Depemokimab in Two Respiratory Diseases
GSK plc (GSK - Free Report) recently announced that EMA has accepted the regulatory filing seeking approval for its IL-5 inhibitor depemokimab in two respiratory indications – asthma with type II inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP).
With regard to the asthma indication, the GSK submission seeks approval for the drug in individuals aged 12 years and older. Concerning CRSwNP, GSK intends to secure approval in adults. Similar regulatory filings for the drug have also been validated for review in China and Japan.
If approved, depemokimab will be the first ultra-long-acting biologic that requires the administration of only one dose every six months.
The GSK drug is yet to be approved for use in any country.
GSK Stock Performance
Shares of GSK have lost 10% in the past year compared with the industry’s 11% decline.
Image Source: Zacks Investment Research
More on GSK’s Depemokimab Filings
GSK’s regulatory filings are supported by positive data from two late-stage programs – SWIFT and ANCHOR. While the SWIFT studies evaluated depemokimab in asthma indications, the ANCHOR studies assessed the drug for CRSwNP.
The SWIFT studies achieved their co-primary endpoints – treatment with depemokimab led to a statistically significant reduction in nasal polyp size and nasal obstruction compared to placebo plus standard of care at 52 weeks.
The ANCHOR studies also met their primary endpoints – treatment with the drug resulted in statistically significant and clinically meaningful reductions in exacerbations (asthma attacks) over 52 weeks versus placebo.
Depemokimab is designed to target IL-5, a key protein in type II inflammation. This inflammation pathway affects most patients with difficult-to-treat asthma, increasing the risk of exacerbations and hospitalization. It is also found in up to 80% of people with CRSwNP, leading to more severe symptoms and disease progression.
Apart from the above two indications, depemokimab is also being evaluated in late-stage studies for other IL-5-mediated diseases. These include the OCEAN studies for eosinophilic granulomatosis with polyangiitis (EGPA) and DESTINY studies in hypereosinophilic syndrome (HES) indication.
Other Players in the Respiratory Diseases Market
If approved, GSK’s depemokimab will face stiff competition from Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) blockbuster IL-4 and IL-13 inhibitor, Dupixent. This blockbuster SNY/REGN drug is currently approved in several countries (including the United States and EU) across multiple type II inflammatory diseases, which include asthma, COPD and CRSwNP.
In September, the FDA expanded Dupixent’s label in the CRSwNP indication for use in adolescent patients aged 12 to 17 years. The drug has already been approved to treat adults with the condition since 2019.
Besides Dupixent, the drug could also face strong competition from AstraZeneca’s (AZN - Free Report) Fasenra, also an IL-5 inhibitor. This AZN drug is currently approved for two indications, namely eosinophilic asthma and EGPA. AstraZeneca is also evaluating the drug in late-stage studies for COPD and HES indications.
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