Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mepolizumab 100 milligrams · 1 trial · 1 indication
Clinically significant exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance Oral Corticosteroids (OCS) therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted Forced Expiratory Volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.
| Arm | Type | Description |
|---|---|---|
| Mepolizumab 100mg | EXPERIMENTAL | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis |
| Name | Type | Description |
|---|---|---|
| Mepolizumab 100 milligrams | DRUG | Mepolizumab will be given as a lyophilized cake in sterile vials for individual use. The vial will be reconstituted with Sterile Water for Injection, just prior to use. |
| Placebo | DRUG | Placebo will be given as 0.9 percent sodium chloride solution. |
| Salbutamol | DRUG | Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study. |
Inclusion Criteria: * Subjects who will be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficien...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Mepolizumab 100 milligrams is used to treat severe asthma. It is a monoclonal antibody developed by GSK plc for patients with this respiratory condition, and it is given as a 100 milligram dose. The clinical program for this dose has focused on severe asthma in a biomarker-selected population.
Mepolizumab 100 milligrams targets interleukin-5, or IL5. It is an IL5 inhibitor, meaning it acts on this cytokine pathway. By binding IL5, the monoclonal antibody interferes with the signaling that drives eosinophilic inflammation, which is relevant in severe asthma.
Mepolizumab 100 milligrams is developed by GSK plc, which trades under the ticker GSK. GSK is the company behind the clinical development program for this monoclonal antibody in severe asthma.
Mepolizumab 100 milligrams has been studied in Phase 3 clinical development. The Phase 3 trial in severe asthma has completed. This drug asset is an investigational therapy in clinical development rather than a newly approved product, based on the development stage recorded for this program.
Mepolizumab 100 milligrams has been evaluated in the Phase 3 trial NCT03562195, titled A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma. That trial enrolled 300 participants in China, was randomized, double-blind, and placebo-controlled, included patients aged 12 years and older, and has completed.
Mepolizumab 100 milligrams refers to a specific 100 milligram dose of the monoclonal antibody mepolizumab. The clinical trial NCT03562195 studied this dose in severe asthma. Readers searching for mepolizumab under that dose description are looking at the same active antibody program developed by GSK.