Drugs / Budesonide/Formoterol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 | NCT00252863 | Dec 2004 → May 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| 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. |
| 2021-01-26 | AstraZeneca | Regulatory Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma astrazeneca.com ↗
AstraZeneca’s Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) has been approved in China as an anti-inflammatory reliever to be taken as-needed in response to symptoms to achieve asthma control in patients with mild asthma aged 12 years and older. |
| 2020-12-14 | AstraZeneca | Regulatory Trixeo Aerosphere approved in the EU for maintenance treatment of COPD astrazeneca.com ↗ |
| 2020-10-19 | AstraZeneca | Regulatory Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD astrazeneca.com ↗ |
| 2020-06-24 | AstraZeneca | Results Breztri Aerosphere significantly reduced rate of moderate or severe COPD exacerbations in Phase III ETHOS trial astrazeneca.com ↗
Breztri Aerosphere achieved a 13% reduction (p=0.003) compared with PT009 (budesonide/formoterol fumarate). |
| 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). |
| 2019-05-20 | AstraZeneca | Results New data show Symbicort reduces attacks in mild asthma when used as an anti-inflammatory reliever astrazeneca.com ↗
Symbicort Turbuhaler demonstrated a 51% reduction in the rate of annual asthma exacerbations compared to albuterol. |
| 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 ↗
PT010 also demonstrated reductions in the rate of moderate or severe COPD exacerbations versus PT009 and Symbicort (18% and 17% respectively), which were numerically but not statistically significant improvements. |
| 2018-05-17 | AstraZeneca | Results New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma astrazeneca.com ↗
Symbicort Turbuhaler ‘as needed’ demonstrated superior asthma-symptom control (34.4% versus 31.1%) assessed according to electronically recorded well-controlled asthma weeks (eWCAW) and a 64% reduction in exacerbations versus SABA ‘as needed’. |
| 2017-01-26 | AstraZeneca | Regulatory Symbicort granted paediatric exclusivity in the US astrazeneca.com ↗
26 January 2017 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. |
| 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 ↗
AstraZeneca today announced the company has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for SYMBICORT (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler (pMDI) for the long-term maintenance treatment of asthma in paediatric patients ages 6-11 years. |
| 2009-03-02 | AstraZeneca | Regulatory FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease astrazeneca.com ↗ |
All press releases naming this drug 14 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 NCT00252863 ↗ |
| Route | Inhaled | “Budesonide/Formoterol Turbuhaler 160/4.5 µg” NCT00252863 ↗ |