Drugs / ALIS
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | pulmonary non-tuberculous mycobacterial infection | 2018-05-16 | “NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) has...” insmed.com ↗ “The Company has previously announced that the FDA accepted and considered the NDA for ALIS filed on May 27, 2018.” insmed.com ↗ |
| Filed | US (FDA) | — | pulmonary non-tuberculous mycobacterial infection | 2018-03-29 | “today announced that it has submitted its New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) to the U.S. Food and Drug Administration (FDA)” insmed.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04677569 | Apr 2021 → Nov 2025 | pulmonary non-tuberculous mycobacterial infection | Insmed Incorporated | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-05-22 | Insmed Incorporated | Results Insmed Presents Range of New Study Findings at American Thoracic Society 2023 International Conference insmed.com ↗
This real-world study of adults in the United States with a self-reported, clinician-confirmed diagnosis of refractory Mycobacterium avium complex (MAC) lung disease provided insights on patient perspectives and practices used to mitigate adverse events (AEs) associated with ARIKAYCE (referred to as ALIS in this poster). |
| 2021-05-19 | Insmed Incorporated | Results Insmed Presents Broad Range of Data Across Its Three Programs at the American Thoracic Society 2021 International Conference insmed.com ↗
Findings were presented from a post-hoc analysis of clinical trial data to assess the NNT and NNH for ARIKAYCE. |
| 2020-03-04 | Insmed Incorporated | Results Insmed Announces Publication Discussing the Clinical Management of Common Respiratory Events Associated with ARIKAYCE® (Amikacin Liposome Inhalation Suspension) in the Journal Open Forum Infectious Disease insmed.com ↗
The study shows that the application of management techniques communicated by treating physicians and subsequently practiced by patients were generally effective in improving common respiratory events, such as dysphonia, increased sputum production, increased cough and dyspnea. |
| 2018-10-11 | Insmed Incorporated | Results Insmed Presents New Data at IDWeek 2018 and CHEST Annual Meeting Enhancing the Understanding of MAC Lung Disease and Treatment with ARIKAYCE® (amikacin liposome inhalation suspension) insmed.com ↗
In a poster presentation on October 4, researchers reported the results of a post-hoc analysis of the Phase 3 CONVERT (INS-212) study to evaluate the impact of amikacin susceptibility on culture conversion outcomes in the study. |
| 2018-09-17 | Insmed Incorporated | Results Pivotal Phase 3 Data from CONVERT Study of ALIS in Patients with Treatment-Refractory NTM Lung Disease Caused by MAC Published in American Journal of Respiratory and Critical Care Medicine insmed.com ↗ |
| 2018-08-27 | Insmed Incorporated | Regulatory FDA Advisory Committee Votes 12-2 in Favor of the Safety and Effectiveness of Insmed’s ALIS for the Treatment of NTM Lung Disease Caused by MAC for Adult Patients with Limited or No Treatment Options insmed.com ↗
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the safety and effectiveness of ALIS (amikacin liposome inhalation suspension) for adults with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have limited or no treatment options. |
| 2018-06-15 | Insmed Incorporated | Regulatory Insmed Announces FDA Advisory Committee Meeting to Review ALIS as a treatment for NTM Lung Disease Caused by MAC insmed.com ↗
The tentative date for the meeting is set for August 7, 2018. |
| 2018-05-22 | Insmed Incorporated | Results Insmed Announces Presentations at the American Thoracic Society 2018 International Conference insmed.com ↗
The global CONVERT study met its primary endpoint of culture conversion by Month 6 with statistical significance (p < 0.0001). |
| 2018-05-16 | Insmed Incorporated | Regulatory Insmed Announces FDA Acceptance for Filing of New Drug Application for ALIS in NTM Lung Disease Caused by MAC insmed.com ↗
The FDA granted Insmed's request for Priority Review and has set an action date of September 28, 2018 under the Prescription Drug User Fee Act (PDUFA). |
| 2018-03-29 | Insmed Incorporated | Regulatory Insmed Submits New Drug Application to FDA for ALIS in NTM Lung Disease Caused by MAC insmed.com ↗
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that it has submitted its New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) to the U.S. Food and Drug Administration (FDA) for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). |
| 2018-01-03 | Insmed Incorporated | Results Insmed Announces Additional Data from ALIS (Amikacin Liposome Inhalation Suspension) Phase 3 Clinical Program for Adult Patients with Treatment Refractory NTM Lung Disease Caused by MAC and Reports Progress with Commercial Preparations insmed.com ↗
The interim results announced today from our ongoing INS-212 and INS-312 studies provide confirmation of the initial positive clinical data released in September 2017. |
| 2017-09-05 | Insmed Incorporated | Results Insmed Announces Positive Top-Line Results from Phase 3 CONVERT Study of ALIS (Amikacin Liposome Inhalation Suspension) in Adult Patients with Treatment-Refractory Nontuberculous Mycobacterial (NTM) Lung Disease Caused by Mycobacterium Avium Complex (MAC) insmed.com ↗
The study demonstrated that the addition of ALIS to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum by Month 6 in 29% of patients, compared to 9% of patients on GBT alone (p < 0.0001). |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALIS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04677569 ↗ |
| Route | Inhaled | “Inhalation via nebulization over approximately 6 to 15 minutes” NCT04677569 ↗ |