The U.S. Food and Drug Administration (FDA) has approved AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. This is the first and only respiratory biologic available with the option of administration at home or in a doctor’s office without phenotype or biomarker limits.
The TEZSPIRE® pre-filled pen and self-administration method are also authorized in the European Union (EU) and are undergoing regulatory evaluation in a number of additional nations. Currently, the US, EU, Japan, and other nations have authorized Tezspire for the treatment of severe asthma.
The Only Biologic for Severe Asthma without Phenotypic or Biomarker Restrictions
TEZSPIRE®, the only biologic for severe asthma that does not have phenotypic (such eosinophilic or allergic) or biomarker restrictions in its approved label, has been granted US clearance for self-administration based on the findings from the PATHFINDER clinical trial program, This has included research results from the PATH-BRIDGE Phase I study and the PATH-HOME Phase III trial.
During the PATH-HOME study, the vast majority (92%) of healthcare professionals, patients, and carers were able to successfully administer TEZSPIRE® both in the clinic and at home. The TEZSPIRE® safety profile and benefits in asthma management according to the PATH-HOME trial’s outcomes were in line with earlier clinical studies.
Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, said:
“Severe asthma continues to be a very complex condition to manage, so we welcome the Tezspire pre-filled pen as an option that will empower patients and healthcare providers with increased choice. We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.”
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said:
“Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. With the approval of the pre-filled pen in the US, we can now offer greater flexibility to patients and physicians with the option to administer Tezspire at home or in the clinic.”
About the TEZSPIRE® pre-filled pen
TEZSPIRE® will be offered as a fixed-dose 210mg subcutaneous injection in the form of a pre-filled, single-use syringe (the TEZSPIRE® pre-filled syringe), or single-use auto-injector (the TEZSPIRE® pre-filled pen).
The pre-filled TEZSPIRE® pen makes it easy for patients and caregivers to self-administer the medication at home or at a clinic. For patient guidance, the gadget features an audible click at the beginning and finish of the injection, a safety guard, and a viewing window.
About the Clinical Trials
PATH-HOME was a Phase III multi-centre, open-label, parallel-group trial designed to assess patient, caregiver and healthcare provider-reported functionality and performance of a single-use, pre-filled syringe (PFS) or auto-injector (AI) with a fixed 210mg dose of TEZSPIRE® administered subcutaneously every four weeks in a clinic and in an at-home setting in 216 patients aged 12 years and older with severe asthma.
The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer the TEZSPIRE® pre-filled pen both in the clinic and at home throughout the trial. At-home administration of the TEZSPIRE® pre-filled pen at weeks 12 and 16 was successful in 97% of the patients or caregivers (102/105). The trial also demonstrated for the first time that adolescents can successfully administer TEZSPIRE® using the two devices. The very low proportion of device malfunctions (0.9% of PFS and 0.8% of AIs) provides support that the instructions for use provided to healthcare providers, patients and caregivers is adequate for successful subcutaneous administration of TEZSPIRE® both in the clinic and at home.
PATH-BRIDGE was a single-center, randomized, open-label, parallel-group Phase I trial in healthy people to compare the pharmacokinetic (PK) exposure after a single 210mg dose of Tezspire by using a vial-and-syringe (V-S), PFS or pre-filled AI device.
Following subcutaneous injection through V-S, PFS, or AI, Tezspire, PK exposure was equivalent in all three cases. In addition, all device groups had low rates of injection site responses and low rates of severe injection site discomfort.
In addition to PATH-BRIDGE and PATH-HOME, the PATHFINDER clinical trial program included the crucial NAVIGATOR Phase III study, which showed that TEZSPIRE®, when added to standard therapy and used in individuals with severe asthma, outperformed placebo in every primary and key secondary endpoint.
The Phase III research study known as Navigator was the first to demonstrate significant improvement in severe asthma individuals irrespective of eosinophils by targeting thymic stromal lymphopoietin (TSLP). These findings back up the FDA’s approval granted to Tezspire in September 2018 as a breakthrough therapy for individuals with severe asthma who don’t have an eosinophilic phenotype. Tezspire was the first and only biologic to gain Priority Review status from the FDA in the US for the treatment of asthma in July 2021.
The first-in-class Human Monoclonal Antibody that Blocks TSLP Activity
TEZSPIRE® (tezepelumab) developed by AstraZeneca in partnership with Amgen is the first-in-class human monoclonal antibody that blocks the activity of TSLP, a key epithelial cytokine that is at the center of several inflammatory conditions as well as in initiation and persistence of allergic, eosinophilic, and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.
The severity of the condition has been associated to greater TSLP expression levels in asthma patients. Allergens, viruses, and other airborne particles are known to trigger TSLP production, which is one of the causes of asthma attacks. By preventing immune cells from releasing pro-inflammatory cytokines, or the TSLP blockade may reduce asthma attacks and improve asthma management. TEZSPIRE® has the potential to benefit a large group of people with severe asthma, regardless of biomarker levels, as it operates at the top of the inflammatory cascade.
TEZSPIRE® is licensed for the treatment of severe asthma in the US, the EU, Japan, and other nations. TEZSPIRE® is also being researched for additional possible indications, including as eosinophilic esophagitis(EoE), chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and chronic obstructive pulmonary disease (COPD). Tezepelumab was given Orphan Drug Designation by the FDA in October 2021 to treat EoE.
For more information, visit Amgen.com
Original Source: Amgen – Feb 02, 2023, 09:00 ET – Press Release: TEZSPIRE® APPROVED FOR SELF-ADMINISTRATION IN THE U.S. WITH A NEW PRE-FILLED PEN