Drugs / Bevespi
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Bevespi Aerosphere | COPD, severe early onset | 2017-09-25 | “A Marketing Authorisation Application for Bevespi Aerosphere has been accepted for review by the European Medicines Agency” astrazeneca.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05607719 | Apr 2023 → Jul 2026 | chronic obstructive pulmonary disease | University of Miami | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05495698 | Dec 2022 → Dec 2026 expected | chronic obstructive pulmonary disease | Franciscus Gasthuis | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2020-05-18 | AstraZeneca | Regulatory Bevespi Aerosphere approved in China for patients with COPD astrazeneca.com ↗
AstraZeneca’s Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| 2019-06-19 | AstraZeneca | Regulatory Bevespi Aerosphere approved by the Japanese Ministry of Health, Labour and Welfare for patients with chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). |
| 2018-12-20 | AstraZeneca | Regulatory Bevespi Aerosphere approved in the EU for chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has approved Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
| 2018-10-19 | AstraZeneca | Regulatory CHMP issues a positive opinion for Bevespi Aerosphere for the treatment of chronic obstructive pulmonary disease astrazeneca.com ↗
Today’s positive CHMP opinion means COPD patients in Europe are one step closer to having this new dual bronchodilator treatment available to them. |
| 2018-08-23 | AstraZeneca | Results AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease astrazeneca.com ↗
In the trial, Bevespi Aerosphere demonstrated non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1) but did not demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1. |
| 2018-01-26 | AstraZeneca | Results AstraZeneca reports top-line Phase III KRONOS trial results for PT010 triple combination therapy in chronic obstructive pulmonary disease astrazeneca.com ↗
In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators. |
| 2017-09-25 | AstraZeneca | Results Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD astrazeneca.com ↗ |
| 2017-05-18 | AstraZeneca | Results AstraZeneca to present scientific advancements from growing respiratory portfolio at the American Thoracic Society conference 2017 astrazeneca.com ↗
reduces the risk of first or sustained clinically-important deteriorations versus placebo and monocomponent metered-dose inhalers in COPD patients (Abstract A3594) . |
| 2016-08-30 | AstraZeneca | Results AstraZeneca to present new data highlighting its growing respiratory portfolio and pipeline at European Respiratory Society 2016 astrazeneca.com ↗
The benefit of Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) over a 24-hour period versus tiotropium bromide inhalation spray and placebo (abstract #PA994) |
| 2016-04-25 | AstraZeneca | Regulatory Bevespi Aerosphere™ approved by the US FDA for patients with COPD astrazeneca.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bevespi | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05607719 ↗ |
| Route | Inhaled | “multi-inhaler triple therapy (Qvar + Bevespi)” NCT05495698 ↗ |