Trial Profile
A Multicenter, Randomized, Open-label, Parallel Group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector With Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects With Severe Asthma (PATH-HOME)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Feb 2023
Price :
$35
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At a glance
- Drugs Tezepelumab (Primary)
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Acronyms PATH-HOME
- Sponsors AstraZeneca; AstraZeneca AB; AstraZeneca KK
- 02 Feb 2023 According to an AstraZeneca media release, TEZSPIRE (tezepelumab-ekko) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. This approval was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trials.
- 02 Feb 2023 According to AstraZeneca media release, the company has received the approval from U.S. FDA for self-administration of drug in pre-filled, single use pen for patients aged 12 years and older with severe asthma. The approval was based on the results from this study.
- 12 Jan 2023 According to AstraZeneca media release, the company has received a positive opinion from the European Medicine Agency's Committee for medicinal products for human use (CHMP) for self-administration in a pre-filled, single use pen for patients aged 12 years and older with severe asthma. This approval was based on the results from this study.