Depemokimab

Exdensur is the first and only ultra-long-acting biologic in China for CRSwNP Approval based on ANCHOR trials showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction Patients with CRSwNP continue to face debilitating daily symptoms, underscoring need for novel treatments GSK plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. This follows the NMPA’s recent approval for Exdensur as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.1 The approval of Exdensur in CRSwNP is based on data from the ANCHOR-1 and ANCHOR-2 phase III trials, which showed an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks [treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and ANCHOR-2 -0.6 (-1.0, -0.2) p=0.004] and in nasal obstruction verbal response scale (scale: 0-3) over weeks 49-52 [ANCHOR-1 -0.23 (-0.46, <0.00) p=0.047 and ANCHOR-2 -0.25 (-0.46, -0.03) p=0.025].4 Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo plus standard of care.2 Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation (RI&I), and Head of Translational & Development Sciences, GSK, said: “Given the continued unmet need amongst patients with CRSwNP, today’s approval of Exdensur could redefine care by protecting from the debilitating symptoms of this disease in just two doses a year. This builds on Exdensur’s recent approval in severe asthma, which means more patients in China could have access to this first and only ultra-long-acting biologic.” Almost half of all patients with CRSwNP remain uncontrolled and up to 85% have underlying type 2 inflammation, which is associated with more severe disease.3-5 An ultra-long-acting therapeutic option that provides sustained suppression of type 2 inflammation could support these patients who continue to face daily symptoms. Exdensur has also been approved in the US and China for the treatment of severe asthma, as well as in Japan, the EU, and UK for the treatment of severe asthma and CRSwNP.1,6-9 About CRSwNP CRSwNP is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.3,10 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.3,10 Similar to asthma, the majority of cases of CRSwNP are driven by chronic type 2 inflammation, which is strongly associated with comorbidities, more severe disease, recurring symptoms and tissue remodelling.3,5,10-13 About Exdensur (depemokimab) Exdensur is the first ultra-long-acting biologic being evaluated for certain respiratory diseases with underlying type 2 inflammation. It combines high interleukin-5 (IL-5) binding affinity and high potency with an extended half-life to enable twice-yearly dosing. IL-5 is a key cytokine in type 2 inflammation.2 For product and important safety information please consult the country’s relevant summary of product characteristics. The EU product information is available at: https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur The US product information is available at: EXDENSUR-PI-PIL.PDF About the ANCHOR phase III trials Full results from the ANCHOR trials were presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.2,14 ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm. All 528 patients had inadequately controlled CRSwNP, including nasal polyps in both nasal cavities (an endoscopic bilateral NPS ≥5), and had either undergone previous surgery for CRSwNP, had received previous treatment with SCS or were intolerant to SCS. Patients received depemokimab or placebo at six-monthly intervals (26 weeks) in addition to SOC (maintenance intranasal corticosteroids).2 About the depemokimab development programme Depemokimab is currently being evaluated in phase III trials for the treatment of other diseases with underlying type 2 inflammation, including OCEAN for eosinophilic granulomatosis with polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome (HES).15,16 GSK has also initiated the ENDURA-1, ENDURA-2 and VIGILANT phase III trials assessing the efficacy and safety of depemokimab as an add-on therapy in patients with uncontrolled moderate to severe COPD with type 2 inflammation.17-19 About GSK in respiratory GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025. References You might also like

While AZ has undergone an audit of its Saphnelo datasets to regain the agency’s trust, GSK faces a more daunting challenge: proving that Exdensur actually works in CRSwNP. The FDA is providing more insight into the rejections it recently handed two pharma giants, publishing the complete response letters (CRLs) sent to AstraZeneca and GSK that highlight shortfalls in the data included in their application packages.In a scathing rebuke (PDF) to AstraZeneca, the FDA cited “critical data quality issues that affect key analyses, including the primary endpoint” within a dataset for Saphnelo (anifrolumab) for the drug’s proposed use in systemic lupus erythematosus (SLE). Separately, the agency rejected (PDF) GSK’s Exdensur (depemokimab) for chronic rhinosinusitis with nasal polyps (CRSwNP), ruling that the clinical data failed to provide “adequate evidence” of efficacy, casting doubts on the drug’s potential expansion in that use.The publication of the rejection letters underscores the FDA’s promise of “radical transparency” regarding its drug review process. While AZ has undergone an audit of its Saphnelo datasets to regain the agency’s trust, GSK faces a more daunting challenge: proving that Exdensur actually works in CRSwNP.For AZ, the CRL was issued on Oct. 10, 2025, according to the FDA’s database. But the company didn’t disclose it until Feb. 3, 2026. At that time, the company said it had submitted the information requested by the FDA in the CRL, and that a decision on the updated application was expected in the first half of this year. AZ’s initial submission was based on an interim analysis of the phase 3 Tulip-SC trial, which showed a reduction in disease activity for subcutaneous Saphnelo versus placebo as measured using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52. However, in the CRL, the FDA flagged that AZ had submitted a “corrected” dataset for the study late in the review cycle after initially making “errors” in the application.As a result, the FDA asked AZ to provide, among other things, a “corrected interim clinical study report” and corrected raw datasets for both the interim and final analyses, presented in formats standard for regulatory reviews. Additionally, the FDA asked the company to “provide a detailed discussion of what led to the errors in the locked database being found,” as well as “a subject-level listing of all the changes in all the datasets along with the reason for each change.”Two months following the FDA’s rejection, European regulators authorized subcutaneous Saphnelo in SLE. This is not the first time that AZ has found itself dealing with data quality issues in a drug application for a kidney disease treatment. Back in 2021, AZ’s then-partner FibroGen filed for an FDA approval but then admitted to manipulating the safety data of roxadustat in chronic kidney disease-related anemia, data that the two firms unveiled to much fanfare in 2019.Roxadustat has since been rejected by the FDA, and AZ exited the collaboration in the U.S. in 2024. Efficacy questions for GSK Meanwhile, GSK faces a different hurdle for Exdensur, as the FDA has asked for “new evidence” that can demonstrate a treatment effect of greater magnitude to prove that the antibody drug provides a “statistically persuasive and clinically meaningful” benefit to CRSwNP patients. In its CRL to GSK, the FDA acknowledged that the co-primary endpoints of the Anchor-1 and -2 trials were met, showing statistically significant improvements for Exdensur versus placebo on nasal polyp scores and nasal obstruction scores. However, on the nasal obstruction score measure, the FDA found the outcomes were “not robust to sensitivity analyses for missing data and handling of intercurrent events.” The FDA views results from the patient-reported endpoint “especially important for assessing benefit-risk because they are a direct reflection of the clinically meaningful effects for patients.”The magnitude of the effects for both primary endpoints was “numerically small,” so the FDA questioned their clinical meaningfulness.The agency’s review team also looked at secondary endpoints, including additional patient-reported symptom scores, the need for nasal sinus or polyp surgery, and oral corticosteroid use. However, because of the statistical design of the studies, none of those endpoints met statistical significance, despite trends favoring Exdensur.The FDA went on further to suggest that a higher dose than the 100 mg selected by GSK “may provide a greater treatment effect,” faulting GSK for not running phase 2 dose-ranging trials specifically in CRSwNP.To tip the review balance further against GSK, the FDA said the every-half-year dosing—a long-acting feature that GSK has touted—means that non-responders would either have to wait a long time to switch to another drug, or risk any issues from taking two biologic therapies while Exdensur is still present in their bodies. “Given the small effect size for depemokimab with lack of robustness on tipping point analysis, the benefit-risk in the setting of a six-month duration of action is not favorable,” the FDA concluded. While the FDA declined to approve Exdensur in CRSwNP, the agency approved the long-acting IL-5 agent as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype. The drug is approved in the EU for both indications.“We remain confident in the benefit Exdensur could bring for patients with CRSwNP and are continuing discussions with the FDA,” a GSK spokesperson told Fierce Pharma. GSK’s focus in the U.S. is on severe asthma, which affects about two million Americans with more than half uncontrolled on current therapy, as well as chronic obstructive pulmonary disease (COPD), the spokesperson added.Exdensur is a key element of GSK's plan to reach more than 40 billion pounds sterling in annual revenue by 2031, a task that has recently fallen on the shoulders of new CEO Luke Miels. In a more important indication than CRSwNP, GSK is testing Exdensur in three phase 3 trials in COPD.