Drugs / budesonide/formoterol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed intermittent asthma 1 milestone | |||||
| Filed | EU (EMA) | Symbicort Turbuhaler | intermittent asthma | 2019-05-20 | “A regulatory submission to expand the indication for Symbicort Turbuhaler as an anti-inflammatory reliever in mild asthma has been accepted in Europe.” astrazeneca.com ↗ |
| Rejected asthma 1 milestone | |||||
| Rejected (CRL) | US (FDA) | SYMBICORT | asthma | 2009-04-06 | “received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for SYMBICORT” astrazeneca.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00288379 | Oct 2004 → May 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-02-13 | AstraZeneca | Results Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for Breztri in patients with uncontrolled asthma published in The Lancet Respiratory Medicine astrazeneca.com ↗
In the pooled analysis of KALOS and LOGOS, Breztri also demonstrated clinically meaningful reductions in the annualised rate of severe asthma exacerbations versus ICS/LABA medicines in patients with or without a recent asthma exacerbation. |
| 2020-10-19 | AstraZeneca | Regulatory Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD astrazeneca.com ↗
AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been recommended for marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist. |
| 2019-09-25 | AstraZeneca | Results AstraZeneca to present next wave of science in respiratory disease at ERS International Congress astrazeneca.com ↗
Multiple ascending dose study of the inhaled IL-4Ra antagonist, AZD1402/PRS-060, in mild asthmatics demonstrates robust FeNO reduction and a promising clinical profile for the treatment of asthma |
| 2019-06-19 | AstraZeneca | Regulatory Breztri Aerosphere (PT010) approved in Japan for patients with chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced that Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD). |
| 2018-09-16 | AstraZeneca | Results The Lancet Respiratory Medicine publishes first Phase III trial for PT010 triple combination therapy in moderate to very severe chronic obstructive pulmonary disease astrazeneca.com ↗
The data were presented today at the European Respiratory Society (ERS) International Congress 2018 in Paris, France, and published in The Lancet Respiratory Medicine . |
| 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. |
| 2017-05-18 | 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 |
| 2017-01-26 | AstraZeneca | Regulatory Symbicort granted paediatric exclusivity in the US astrazeneca.com ↗
AstraZeneca today announced that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol. |
| 2016-05-12 | AstraZeneca | Results AstraZeneca to highlight the breadth of its respiratory medicines at American Thoracic Society 2016 International Conference astrazeneca.com ↗
The novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI significantly improves health status in symptomatic patients with COPD |
| 2013-03-19 | AstraZeneca | Results Real world study comparing commonly prescribed COPD medicines shows choice of treatment has impact on patient outcomes astrazeneca.com ↗
Overall, budesonide/formoterol reduced the annual rate of moderate to severe exacerbations by 26% compared to fluticasone/salmeterol (0.80 vs. 1.09 /patient-year; p<0.0001). |
| 2010-06-02 | AstraZeneca | Regulatory FDA updates US product labels for LABA-containing medications including AstraZeneca’s SYMBICORT astrazeneca.com ↗
Today, the US Food and Drug Administration (FDA) released final label revisions for respiratory medications that contain an active ingredient known as a long-acting beta-agonist (LABA). |
| 2009-04-06 | AstraZeneca | Regulatory AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old astrazeneca.com ↗ |
| 2009-03-02 | AstraZeneca | Regulatory FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease astrazeneca.com ↗ |
All press releases naming this drug 15 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 | budesonide/formoterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00288379 ↗ |
| Known as | Symbicort Turbuhaler | “the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg)” NCT00288379 ↗ |