Fluticasone Propionate

GSK announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as add-on therapy with intranasal corticosteroids for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is inadequately controlled by systemic corticosteroids and/or surgery. The approval positions depemokimab as the first ultra-long-acting biologic available in China for this indication, and follows the NMPA’s recent clearance of the same molecule for severe eosinophilic asthma in patients aged 12 years and older. Exedensur has now secured CRSwNP approvals across major markets including the EU, UK, Japan, and China, but not in the US, where the FDA has approved the molecule only for severe asthma and issued a Complete Response Letter (CRL) for CRSwNP, stating that the filing failed to provide “adequate evidence” of efficacy. The China CRSwNP indication covers adults who have not achieved adequate disease control despite systemic corticosteroid use or surgical intervention. Depemokimab is administered as an add-on to maintenance intranasal corticosteroids, with dosing at six-monthly intervals — a schedule that distinguishes it from other approved biologics in this class, which require monthly or biweekly administration. The NMPA decision was supported by data from the ANCHOR-1 and ANCHOR-2 Phase III trials, which enrolled 528 adults with inadequately controlled CRSwNP, bilateral nasal polyps, and an endoscopic bilateral nasal polyp score of 5 or higher. All participants had prior CRSwNP surgery, prior systemic corticosteroid use, or intolerance to systemic corticosteroids. Patients received depemokimab or placebo every 26 weeks alongside standard-of-care intranasal corticosteroids. At 52 weeks, depemokimab produced statistically significant reductions in nasal polyp score versus placebo: treatment differences of −0.7 (95% CI −1.1 to −0.3; p<0.001) in ANCHOR-1 and −0.6 (95% CI −1.0 to −0.2; p=0.004) in ANCHOR-2. Nasal obstruction scores over weeks 49–52 also improved, with treatment differences of −0.23 (p=0.047) and −0.25 (p=0.025) in the two trials respectively. The tolerability profile was comparable to placebo plus standard of care. Full results were published in The Lancet and presented at the 2025 AAAAI/WAO Joint Congress. CRSwNP is driven by chronic inflammation of the nasal lining, producing soft tissue polyps that cause nasal obstruction, loss of smell, facial pain, sleep disturbance, and recurrent infections. According to GSK, approximately half of patients with CRSwNP remain uncontrolled on existing therapies, and up to 85% have underlying type 2 inflammation — a cytokine-mediated endotype associated with more severe disease and tissue remodelling. Depemokimab targets interleukin-5 (IL-5), a cytokine central to eosinophil survival and activation within the type 2 inflammatory pathway. Its engineered extended half-life enables the twice-yearly dosing interval, which GSK the company said represents a potential adherence advantage over currently available options. The CRSwNP biologic landscape has expanded considerably since dupilumab (Dupixent, Regeneron/Sanofi) received the first approval in this indication in 2019, targeting the shared IL-4/IL-13 receptor component. Omalizumab (Xolair, Genentech/Novartis), an anti-IgE antibody, followed with a CRSwNP approval in 2020, and mepolizumab (Nucala, GSK) — which shares depemokimab’s IL-5 target — was approved in 2021. Most recently, tezepelumab (Tezspire, Amgen/AstraZeneca), which acts upstream by targeting the alarmin TSLP, received US FDA approval for CRSwNP in October 2025. Exdensur (depemokimab) holds CRSwNP approvals in the EU, UK, Japan, and now China; its FDA status for this indication has not been confirmed in available sources, though the molecule received US approval for severe asthma. Within this field, depemokimab’s twice-yearly dosing interval is a pharmacokinetic differentiator relative to agents requiring monthly or biweekly injections. Whether that attribute translates into meaningful adherence or outcome differences in clinical practice remains to be established in real-world settings. GSK is also evaluating depemokimab across a broader type 2 inflammatory disease spectrum: Phase III trials are underway in eosinophilic granulomatosis with polyangiitis (OCEAN trial) and hypereosinophilic syndrome (DESTINY trial), alongside the ENDURA-1, ENDURA-2, and VIGILANT programs in uncontrolled moderate-to-severe COPD with type 2 inflammation — an indication where biologics have historically faced limited success but where biomarker-enriched patient selection may improve the probability of benefit. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Sanofi said Tuesday that lunsekimig cleared the primary and key secondary goals in two Phase II studies evaluating the investigational bispecific pentavalent nanobody, which targets TSLP and IL-13, for moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). However, an exploratory mid-stage trial in atopic dermatitis missed its target.AIRCULES and DUET deliverIn the Phase IIb AIRCULES study enrolling 685 patients with moderate-to-severe asthma across fractional exhaled nitric oxide (FeNO) or eosinophil biomarker values, lunsekimig versus placebo at week 48 achieved the primary endpoint of significant and clinically meaningful reduction in annualised asthma exacerbation rates and a key secondary goal of improvement in lung function, as measured by pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1).Separately, the Phase IIa DUET study enrolled 79 patients with CRSwNP inadequately controlled on intranasal corticosteroids. Lunsekimig met the primary endpoint of change in nasal polyp score from baseline, along with key secondary goals measuring nasal congestion/obstruction score and Lund-Mackay CT score, all at week 24, compared with placebo."These findings underscore lunsekimig's potential to address multiple critical aspects of respiratory disease management through its unique mechanism," said Houman Ashrafian, R&D head at Sanofi.VELVET comes up shortMeanwhile, the exploratory Phase IIb VELVET study failed to meet its primary endpoint of percentage change from baseline versus placebo on the eczema area severity index (EASI) score at week 24 in 150 participants with moderate-to-severe atopic dermatitis. Improvements were nonetheless observed in key secondary goals, including EASI-75 response rates and validated investigator global assessment scale for atopic dermatitis (vIGA-AD) 0/1 scores.Sanofi said that across all three studies, lunsekimig was generally well tolerated, with rates of serious adverse events and treatment discontinuations in AIRCULES and DUET broadly comparable between active and placebo groups."We currently forecast peak lunsekimig sales of €2.5 billion," Morgan Stanley analysts said last month, with the drug having potential to reach Sanofi's €3 billion to €5 billion guidance should atopic dermatitis and asthma data support.Sanofi is also evaluating lunsekimig in the Phase II AIRLYMPUS study in high-risk asthma, as well as in the chronic obstructive pulmonary disease late-stage studies PERSEPHONE and THESEUS.For more on the evolving anti-TSLP landscape in asthma, which is championed by AstraZeneca and Amgen's Tezspire (tezepelumab), see – Spotlight On: Can next-gen anti-TSLP drugs overcome Tezspire's lead in asthma?