Drugs / Budesonide/Formoterol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 2 milestones | |||||
| 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 ↗ |
| Filed | Japan (PMDA) | Symbicort Turbuhaler | asthma | — | “AstraZeneca submitted a new drug application (NDA) in Japan in May, 2007.” astrazeneca.com ↗ |
| 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 ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00242411 | Sep 2004 → Oct 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| 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. |
| 2025-05-02 | AstraZeneca | Results Breztri met primary endpoints in KALOS and LOGOS Phase III trials in asthma astrazeneca.com ↗ |
| 2021-03-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Inc. and Kindeva Drug Delivery Announce FDA Tentative Approval of the First Abbreviated New Drug Application Generic Version of Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol viatris.com ↗
Viatris Inc. (NASDAQ: VTRS) and Kindeva Drug Delivery L.P. today announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort ® based on an Abbreviated New Drug Application (ANDA). |
| 2019-08-28 | AstraZeneca | Results Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease astrazeneca.com ↗
At the standard budesonide dose, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg). |
| 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. |
| 2018-09-13 | AstraZeneca | Results AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018 astrazeneca.com ↗
Adding budesonide to formoterol reduces risk of clinically important deteriorations (CID) in moderate to very severe COPD |
| 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. |
| 2016-09-06 | GlaxoSmithKline | Results GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗
In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41; p<0.001). |
| 2016-06-20 | GlaxoSmithKline | Results FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients gsk.com ↗
The proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on FF/UMEC/VI and 41% on budesonide/formoterol. |
| 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). |
| 2011-09-26 | AstraZeneca | Regulatory AstraZeneca announces first approval of FASLODEX™ (fulvestrant) in Japan astrazeneca.com ↗ |
| 2010-06-02 | AstraZeneca | Regulatory FDA updates US product labels for LABA-containing medications including AstraZeneca’s SYMBICORT astrazeneca.com ↗
The updated label for combination asthma medications, including SYMBICORT, provides guidance on how these products should be prescribed to treat asthma, including: |
All press releases naming this drug 23 releases
Evidence & citations 3 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 NCT00242411 ↗ |
| Known as | Symbicort | “flexible dose of Symbicort (budesonide/formoterol)” NCT00242411 ↗ |
| Route | Inhaled | “Symbicort® Single Inhaler Therapy” NCT00242411 ↗ |