Amgen and AstraZeneca Launch Tezspire (tezepelumab-ekko) in the U.S. for Severe Asthma: First-in-Class TSLP-Targeting Biologic with Broad Patient Applicability

News on January 14, 2022 /BioValleyBIOON/ -- Amgen (Amgen) andAstraZeneca(AstraZeneca) recently announced the launch of Tezspire (tezepelumab-ekko) in the U.S. market. The drug was approved by the FDA in December 2021 as an add-on maintenance treatment for severe asthma in pediatric and adult patients aged 12 years and older. Tezspire received approval through the FDA’s priority review process. In September 2018, the United StatesFDAGranted Tezepelumab for the Treatment of Severe Non-Eosinophilic PhenotypeAsthmaBreakthrough Therapy Designation (BTD).

Tezspire is a first-in-class biologic for the treatment of severe asthma, acting at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP). TSLP is an epithelial cytokine that plays a key role in...AsthmaPlays a key role in inflammation.

It is worth mentioning that,In the treatment of severe asthma, Tezspire is the first and only biologic without phenotypic (such as eosinophilic or allergic) orBiomarkerRestricted biologics. This is the first time for many severeAsthmaPatients have the opportunity to receive treatment regardless of the inflammatory cause of their disease.

Due to severeAsthmaThe complexity and heterogeneity, despite some progress in recent years, many patients still often experience worsening conditions, increased risk of hospitalization, and a significant reduction in quality of life.

The launch of Tezspire has the potential to transform the treatment for a wide range of patients with severe asthma.In Phase 2 and Phase 3Clinical TrialIn China, regardless of the keyBiomarker(Including: eosinophil count, allergic status, fractional exhaled nitric oxide [FeNO]), Tezspire consistently and significantly reduces asthma exacerbations, including those of broad and severe types.AsthmaPatient.

Murdo Gordon, Executive Vice President of Global Commercial Operations at Amgen, stated: "Severe asthma has historically been a complex disease. Approximately 60% of patients have multiple disease drivers and may respond poorly to existing treatments. Tezspire is suitable for a broad range of severe...Asthma"Patients, we look forward to delivering this important drug to millions of patients whose medical needs are unmet."

Mechanism of Action of Tezepelumab (Image Source: PMID:33050900)

United StatesFDAApproval of Tezspire was based on positive data from the PATHFINDER clinical program, including positive results from the pivotal Phase 3 NAVIGATOR trial. The trial demonstrated: in a broad population of severe uncontrolledAsthmaIn patients, tezepelumab demonstrated superiority over placebo across all primary endpoints and key secondary endpoints.

The NAVIGATOR trial is the first Phase III trial to demonstrate therapeutic benefits for severe asthma by targeting TSLP.Data show that: in the entire patient population, compared with placebo + standard of care (SoC), tezepelumab + SoC treatment over 52 weeksAsthmaThe annualized asthma exacerbation rate (AAER) was significantly reduced by 56%, with a statistically and clinically significant difference (AAER: 0.93 vs 2.10; RR=0.44; p<0.001). Regardless of blood eosinophil count, allergic status, or FeNO levels, patients receiving tezepelumab showed a significant reduction in AAER compared to placebo. In this trial, the standard of care (SoC) consisted of medium- or high-dose inhaled corticosteroids (ICS) plus an additional controller medication, with or without oral corticosteroids (OCS).

Moreover, in the subgroup of patients with baseline eosinophil count <300 cells/μL, the trial also met its primary endpoint: compared with placebo + SoC, tezepelumab + SoC treatment resulted in a statistically significant and clinically meaningful reduction in AAER. A similar reduction in AAER was observed in the subgroup of patients with baseline eosinophil count <150 cells/μL. In this study, tezepelumab was well-tolerated in severe...AsthmaPatients showed good tolerance, and there was no clinically meaningful difference in safety outcomes between the tezepelumab group and the placebo group.

Treating severe asthma is a significant challenge due to the complexity of the disease in patients, often caused by multiple inflammatory pathways. These results highlight the broad and profound impact of tezepelumab on severe asthma.AsthmaThe transformative potential of treatment for patients (regardless of their type of inflammation).

NAVIGATORClinical TrialData

TSLP is an epithelial cytokine produced in response to pro-inflammatory stimuli, such as inhaled allergens, viruses, and other pathogens in the lungs, playing a key role in the onset and persistence of airway inflammation. TSLP drives the release of downstream T2 cytokines, including IL-4, IL-5, and IL-13, leading to inflammation and asthma symptoms. TSLP can also activate various types of cells involved in non-T2 driven inflammation. Thus, the early upstream activity of TSLP in the inflammatory cascade has been identified as a potential target in a broad population of asthma patients. Blocking TSLP can prevent immune cells from releasing pro-inflammatory cytokines, thereby preventing asthma exacerbations and improving asthma control.AsthmaControl.

The active pharmaceutical ingredient in Tezspire is tezepelumab, a first-in-class anti-TSLP monoclonal antibody that specifically binds to human TSLP and blocks its interaction with the receptor complex. This prevents the release of pro-inflammatory cytokines by TSLP-targeted immune cells, thereby averting asthma attacks and improving asthma control. Due to its action on the early upstream of the inflammatory cascade, tezepelumab may be suitable for a broad population of patients with severe uncontrolled asthma.AsthmaPatients, regardless of patient phenotype or T2BiomarkerStatus.

Severe asthma is a debilitating disease that affects approximately 34 million people worldwide. Due to the complexity of severe asthma, many patients continue to experience symptoms despite receiving standard-of-care inhaled medications, currently available biologic therapies, and oral corticosteroids (OCS).AsthmaPatients will continue to experience symptoms and frequent exacerbations.

Tezspire works differently from any other asthma biologic drug, targeting multiple inflammatory pathways that contribute to asthma symptoms and exacerbations. Tezspire has the potential to transform the landscape for a broad population of severely underserved patients.AsthmaCare for the patient population, including those without an eosinophilic phenotype.

Currently, Tezspire is being co-developed by AstraZeneca and Amgen. The industry believes that,The approval and launch of Tezspire will be inAsthmaThe therapeutic field is掀起一场腥风血雨, and its target patient population will far exceed that of currently marketed biologic therapies.IncludingGSKNucala (mepolizumab, targeting IL-5) from GSK, Teva's Cinqair (reslizumab, targeting IL-5), and biologic therapies currently in development for asthma treatment, such as AstraZeneca's own benralizumab (targeting the IL-5 receptor alpha subunit [IL-5Rα]) and Sanofi's Dupixent (targeting IL-4/IL-13), all four of these therapies only target specific inflammatory molecules driving asthma inflammation and are only suitable for certain types of severe asthma patients, namely subgroup patients, such as those with eosinophilic asthma.Asthma.(Bioon.com)

Source of Original Text:TEZSPIRE (TEZEPELUMAB-EKKO) NOW AVAILABLE IN THE UNITED STATES FOR THE TREATMENT OF SEVERE ASTHMA