Trial Profile
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avi
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 29 Feb 2024
Price :
$35
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At a glance
- Drugs Amikacin (Primary) ; Azithromycin; Ethambutol
- Indications Lung disorders; Mycobacterium avium complex infections; Nontuberculous mycobacterium infections
- Focus Registrational; Therapeutic Use
- Acronyms ARISE
- Sponsors Insmed
- 22 Feb 2024 According to an Insmed media release, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan recently confirmed that it would not consider a label expansion for ARIKAYCE based on data from the ARISE study alone due to (i) the lack of Japanese subjects in that study; (ii) the absence of what PMDA considers a sufficiently long treatment exposure (12 months); and (iii) the absence of resulting evidence of culture conversion the PMDA considers durable (15 months).
- 05 Jan 2024 According to an Insmed media release, company received encouraging written feedback from U.S. Food and Drug Administration (FDA) on the patient-reported outcome data produced in this Phase 3 ARISE study in Dec 2023.
- 26 Oct 2023 According to an Insmed media release, Based on the results of ARISE study ,the company is investing with global regulators accelerating the filing for approval of ARIKAYCE in newly infected patients with MAC lung disease.