GSK plc (LSE/NYSE: GSK) has received approval from Japan's Ministry of Health, Labour and Welfare for Nucala (mepolizumab) to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults who are inadequately controlled with standard treatments. This approval, announced today, marks Nucala as the first biologic in Japan with a four-weekly dosing schedule for this condition.
CRSwNP is a chronic inflammatory disease of the nasal passages that can cause nasal obstruction, loss of smell, and other symptoms affecting patients' quality of life. In Japan, an estimated 2 million people suffer from chronic rhinosinusitis, with approximately 200,000 undergoing surgery for nasal polyps.
The approval is based on the phase III MERIT trial and supported by data from the global phase III SYNAPSE study. These studies demonstrated that mepolizumab significantly improved nasal obstruction and had a numerical reduction in nasal polyp score. The treatment also improved patient quality of life as measured by the Sino-Nasal Outcome Test (SNOT-22). Safety and tolerability data were consistent with the known profile of mepolizumab.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK, commented on the approval, noting the underestimated impact of CRSwNP on patients and the potential of Nucala to provide an alternative to surgery or systemic steroids.
Nucala, a monoclonal antibody targeting IL-5, is already approved in Japan for other conditions, including bronchial asthma in children and adults with refractory asthma, as well as adult patients with eosinophilic granulomatosis with polyangiitis.
GSK's respiratory portfolio is focused on delivering improved outcomes for patients with various respiratory diseases, including asthma and COPD. This latest approval of Nucala in Japan is a continuation of the company's commitment to addressing unmet needs in respiratory care.
The information in this article is based on a press release statement from GSK plc.
In other recent news, GlaxoSmithKline (NYSE:GSK) has experienced a series of significant developments. The company's investigational treatment for chronic hepatitis B, bepirovirsen, has been awarded SENKU designation by the Japanese Ministry of Health, Labour and Welfare, signifying an expedited review process due to the therapy's potential to address serious unmet medical needs.
On the legal front, GSK is under scrutiny as the Delaware Supreme Court reviews a lower court ruling concerning the admissibility of expert testimony in the ongoing Zantac litigation. The company maintains that there is no reliable scientific evidence linking the drug to an increased risk of cancer.
In terms of financial performance, GSK reported a 13% increase in Q2 sales to £7.9 billion and a 21% rise in core operating profit to £2.5 billion, leading to an upgraded full-year guidance. Analyst ratings have been mixed, with Deutsche Bank and Berenberg reaffirming their Buy ratings on GSK, while JPMorgan maintained its Underweight rating.
In product development, GSK's investigational drug GSK5764227 for the treatment of extensive-stage small-cell lung cancer has been granted Breakthrough Therapy Designation by the FDA. The FDA also approved the expanded use of Jemperli, a key product in GSK's immuno-oncology portfolio, for the treatment of endometrial cancer. These developments are part of the recent news surrounding GSK.
InvestingPro Insights
As GSK plc (LSE/NYSE: GSK) expands its portfolio with the recent approval of Nucala in Japan, investors may consider the company's financial health and market performance. GSK's market capitalization stands at a robust $88.73 billion, reflecting its significant presence in the pharmaceutical industry. The company's P/E ratio, a measure of its current share price relative to its per-share earnings, is at 16.59, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at an even more attractive 9.8. This suggests that the company's earnings are strong relative to its share price.
Additionally, GSK's revenue growth of 7.2% over the last twelve months as of Q2 2024 indicates a healthy expansion of its business operations. One of the InvestingPro Tips highlights that GSK is a prominent player in the Pharmaceuticals industry, an assertion supported by its gross profit margin of 72.78% for the same period, which underscores the company's ability to maintain profitability.
For those interested in dividend income, GSK has maintained dividend payments for 24 consecutive years, with a current dividend yield of 3.43%, and a 7.0% dividend growth in the last twelve months as of Q2 2024. This consistent return to shareholders is a testament to GSK's financial resilience and commitment to providing shareholder value. For more detailed analysis and additional InvestingPro Tips, including insights on shareholder yield and the company's ability to cover interest payments, investors can visit the dedicated GSK page on InvestingPro. Currently, there are 9 more tips available that can offer further guidance on GSK's investment potential.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.