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GSK plc (LSE/NYSE: GSK), a prominent pharmaceutical company with a market capitalization of $71.29 billion and currently undervalued according to InvestingPro Fair Value metrics, has reached a significant milestone as the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application for depemokimab, an innovative biologic therapy for asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). This acceptance, announced today, is based on the promising results from the SWIFT and ANCHOR clinical trials.
If approved, depemokimab would be the first ultra-long-acting biologic with a six-month dosing schedule for these conditions. This could potentially transform treatment paradigms by reducing the frequency of doses required, thereby improving patient adherence and outcomes.
The SWIFT-1 and SWIFT-2 trials demonstrated that depemokimab, as an add-on therapy, significantly reduced exacerbation and hospitalization rates in patients with type 2 inflammation asthma. Similarly, the ANCHOR-1 and ANCHOR-2 studies found that depemokimab effectively reduced the size and obstruction of nasal polyps compared to placebo.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK, expressed confidence in depemokimab's potential to alleviate the burden of both asthma and CRSwNP for patients and health systems. He emphasized the drug's ability to offer sustained inhibition of IL-5, a key driver of type 2 inflammation, with just two doses per year.
Depemokimab targets interleukin-5 (IL-5), a cytokine involved in type 2 inflammation, which is a common underlying factor in several diseases including asthma and CRSwNP. This inflammation often leads to exacerbations and hospitalizations in asthma and is associated with more severe disease in CRSwNP.
In Europe, asthma affects over 42 million people, with an estimated societal cost of 46 billion euros annually. CRSwNP, on the other hand, affects up to 4% of the general population, with 40% of these patients having uncontrolled disease.
The development program for depemokimab includes phase III trials for asthma and CRSwNP, as well as ongoing evaluations for other IL-5 mediated diseases. Notably, depemokimab is not yet approved for use in any country. GSK's robust financial health, with a "GREAT" overall score on InvestingPro's comprehensive assessment and an impressive gross profit margin of 72.39%, positions the company well to advance this development program. Investors can access detailed analysis and 8 additional ProTips through InvestingPro's exclusive research reports.
The acceptance of depemokimab by the EMA marks an important step forward for GSK in its mission to redefine respiratory medicine. The company, which has demonstrated solid revenue growth of 5.59% over the last twelve months, is committed to delivering innovative treatments that address the needs of patients with respiratory diseases and improve their quality of life.
With the next earnings announcement scheduled for February 5, 2025, investors seeking deeper insights can access GSK's complete financial analysis through InvestingPro's comprehensive research reports, available for over 1,400 top stocks. This information is based on a press release statement and financial data from InvestingPro.
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