GSK’s Monthly-Administered Mepolizumab Gains FDA Approval for Eosinophilic COPD, Targeting a $3.9 Billion Patient Market

Local time on May 22, GSK（GSK）Announced that the US FDA has approved its IL-5 monoclonal antibodyMepolizumab（Nucala）New Indication Approval, used forAdjunctive Maintenance Treatment for Eosinophilic COPD Patients。

This is the firstApproved for the treatment of COPDIL-5 monoclonal antibody, alsoThe world's first approved biologic for the treatment of COPD patients with once-monthly dosing, representing a breakthrough in COPD treatment.

Screenshot source: Corporate official website

COPD: The New Blue Ocean for Anti-inflammatory Drugs

COPD is a progressive, heterogeneous inflammatory lung disease, including chronic bronchitis and emphysema.More than 390 million people worldwide suffer from COPD,The clinical demand is very large. Among them, there are about 100 million patients in China, more than 14 million patients in the United States, and more than 40 million patients in Europe.

COPD Patients Experience Persistent Respiratory Symptoms Such as Breathlessness, Coughing, and Sputum Production, Along with Progressive Airflow Obstruction Caused by Chronic Inflammation, Impacting Daily Life. Relevant Statistics Show That COPD Is the Third Leading Cause of Death Globally, Resulting in Over 3 Million Deaths Annually.

Despite the use of inhaled triple therapy（ICS+LAMA+LABA）Can improve lung function in patients with COPD and reduce the frequency of acute exacerbations, but many patients still experience persistent symptoms and disease progression. Disease progression refers to acute episodes of worsening COPD symptoms, which may lead to hospitalization and irreversible lung damage, resulting in a gradual decline in lung function. Patients are in urgent need of new treatment options.

The study found,Type 2 inflammation is the underlying pathological mechanism for symptoms and acute exacerbations in up to 40% of COPD patients.Therefore, anti-inflammatory drugs targeting type 2 inflammatory pathway targets such as IL-4R and IL-5 have become a popular research and development direction for COPD.

In 2024, Sanofi/Regeneron's IL-4R monoclonal antibody "Dupilumab" was successively approved in the EU, mainland China, and the United States, becoming the world's first approved biologic-targeted drug for COPD.

Today's approval of mepolizumab has brought COPD patients another targeted drug with a completely new mechanism of action.

The World’s First IL-5 Monoclonal Antibody Achieves Another Milestone

Mepolizumab is the world's first approved IL-5 monoclonal antibody., which has been previously approved in the United States, the European Union, Japan, China, and other countries and regions for the treatment of four IL-5 mediated diseases, including eosinophilic asthma, allergic granulomatous vasculitis, hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps.

IL-5 is a key cytokine in type 2 inflammation, playing a crucial role in the growth, activity, and survival of eosinophils, while also having broad effects on other immune and structural cell types beyond eosinophils, including those involved in inflammation, lung remodeling, and disease progression. Therefore, IL-5 targeted therapies also have potential for the treatment of COPD.

This approval means that Mepolizumab has becomeThe First IL-5 Monoclonal Antibody Approved for the Treatment of COPD、The World's First Biologic Treatment for COPD Administered Once Monthly, and at the same time isThe World's 2nd COPD Biologic。

The approval of mepolizumab for COPD indications was not easy. GSK conducted three Phase III clinical trials of mepolizumab for the treatment of COPD. Among them, the first two studies, METREX and METREO, were initiated in 2014 and completed in 2017, lasting for three years, but the results were not satisfactory. The FDA requested more data to further demonstrate the efficacy of treating COPD.

Based on the experience of the first two studies, GSK conducted a third Phase III clinical trial, MATINEE.（NCT04133909）。This study lastedMore than five years, eventually reaching the primary endpoint, supported the approval of mepolizumab for the COPD indication.

MATINEE Study Historical Timeline

MATINEE is a randomized, double-blind, parallel, placebo-controlled Phase III trial designed to compare mepolizumab 100 mg as an add-on therapy.(Once every 4 weeks by subcutaneous injection, for a total of 52-104 weeks)Triple Therapy Combined with Placebo Inhalation(Dual-Action Long-Acting Bronchodilator + Inhaled Corticosteroid)The efficacy and safety. The study included 804 COPD patients with a history of disease exacerbation and evidence of type 2 inflammation characterized by elevated blood eosinophil counts.

The study concludedFruit has been in"The New England Journal of Medicine" (NEJM)Published.Data show:

• Compared with the placebo group,MepolizumabGroupThe annualized rate of moderate/severe exacerbations was reduced by 21% in patients.，With clinicalClinically and statistically significant, achieving the primary endpoint of the study。

• In a post-hoc analysis of patients clinically assessed as having chronic bronchitis, compared with the placebo group,The annualized rate of moderate/severe exacerbations in the Mepolizumab group was reduced by 31%.。

• Reducing hospitalizations is a key goal in COPD management. In this study, MepolizumabReduced the annualized rate of disease episodes leading to emergency room visits and/or hospitalizations by 35%.。GSK pointed out that mepolizumab is the only biologic agent with data from Phase III clinical trials showing a reduction in emergency department visits and/or hospitalizations.

• Patient-Reported Outcomes in the Mepolizumab Group (PRO)The remission rate was relatively high, but in the St. George's Respiratory Questionnaire（SGRQ）COPE Assessment Test（CAT）In terms of quality of life scores, there was no significant difference between the mepolizumab group and the placebo group.

• The incidence of adverse events was similar for mepolizumab and placebo, with the most common being COPD exacerbation or worsening and COVID-19 infection.

NEJM Invited Expert Commentary States: The study demonstrates that mepolizumab can safely and effectively reduce the risk of acute exacerbations in patients with eosinophilic phenotype COPD, providing a new option for precision treatment. In the future, it will also be necessary to optimize patient stratification using dynamic biomarkers and explore multi-target combination therapy strategies to achieve personalized breakthroughs in COPD management.

GSK has also submitted the marketing application for Mepolizumab COPD indication in the EU and China, which is expected to be approved this year.

Mepolizumab, a key product of GSK, has seen continuous sales growth since its initial approval in November 2015. In 2024, the drug's sales reached $2.279 billion, marking a 10% year-over-year increase.

Source: Insight Database

Currently, GSK is also exploring the potential of Mepolizumab in more indications. In addition to the recently approved COPD, there are chronic rhinosinusitis, eosinophilic esophagitis, nasal polyps, atopic dermatitis, dysphagia, chronic spontaneous urticaria, eosinophilic fasciitis, and more. With the expansion into new indications, the sales of Mepolizumab are expected to grow further.

In addition, to address the upcoming patent expiration of mepolizumab, GSK has also developed a next-generation IL-5 antibody——Dermochimab（Depemokimab）。Dermoquimab is the first ultra-long-acting IL-5 antibody. Compared with Mepolizumab(Once a month)In comparison, Dermochimab has a longer half-life, higher binding affinity, and potency., only requires injection once every six months, which helps improve patient compliance and convenience.

Since 2025, GSK has successively submitted marketing applications for two indications of Dermoquimab in mainland China, Japan, Europe, and the United States, for the treatment of eosinophilic asthma and chronic rhinosinusitis with nasal polyps, respectively.Demochizumab has entered Phase III for COPD. This drug will help GSK maintain its leading position in the IL-5 antibody field.

Development History of Demochizumab

COPD Biologics R&D Heats Up, Over 80 Pipeline Candidates

The pathogenesis of COPD is complex, and its causes have not been fully elucidated. The difficulty in developing new drugs is exceptionally high, with no new drugs emerging for over a decade. It was not until 2024 that the field of COPD welcomed two landmark targeted drugs.

One is Encefabol, a new chemical drug developed by Verona.（Ensifentrine）, approved by the FDA for the maintenance treatment of adult COPD. Ensifentrine is the world's first dual PDE3/4 inhibitor, combining both bronchodilation and anti-inflammatory effects.

Another one is Dupilumab, which is the icebreaker for biologics in the COPD field. Mepolizumab, approved today, represents another breakthrough for biologics in COPD treatment.

Currently, COPD has become a popular direction for biologic drug development. According to the Insight database, there are 87 biologics globally.(Statistics as of 2025/5/7)Research on COPD is underway and poised for breakthroughs.

In terms of research progress, two of them have been approved, and eleven are in Phase III.(Including Phase II/III)Phase, 23 in Phase II(Including Phase I/II)Phase, 28 products in Phase I or approved for clinical trials.

In terms of drug types:The largest number of monoclonal antibodies, with 42 varieties.; followed byMesenchymal Stem Cells, with 12 types; the third most isDual Antibody, with 7 products. In terms of target distribution,TSLP, IL4R, IL33/IL33R, IL5, IL13 have the highest number of target pipelines.。

TOP 20 Target Distribution of COPD Biologics

• In the TSLP track, Amgen/AstraZeneca'sTezepelumabThe fastest-progressing one is currently in Phase III clinical trials; other players include Biosion/CTTQ/Aclaris, Quanxin Biotech/Joincare, Merck, Novartis, etc.

• IL4/IL4R Track: Sanofi/Regeneron's Dupilumab was the first to be approved; Connoymab/Shiyao Group(Supercabtag)3SBio（SSGJ-611）, Connect Biopharma/Simcere Pharmaceutical(Ledokibab)The product is in Phase II.

• In the IL33/IL33R field, three products have entered Phase III, respectively from Amgen/Roche.（Astegolimab）、AstraZeneca（Tozorakimab）、Sanofi/Regeneron(Itolizumab)。

• In the IL5/IL5R field, GSK's Mepolizumab was the first to be approved; Kyowa Kirin/AstraZeneca's Benralizumab and GSK's Demokizumab are already in Phase III.

• In the IL13/IL13R field, Roche/Lilly's lebrikizumab is the furthest along, currently in Phase II.

It is not difficult to see that COPD, with a patient population of 390 million, has become a new battleground for major pharmaceutical companies. Although only two biologics have been approved for the treatment of COPD so far, more biologics will inevitably flood the market as research progresses, and the competition will become even fiercer.

Cover Source:ZCOOL Hailo

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