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 4 | NCT01253473 | Apr 2012 → Sep 2015 | chronic obstructive pulmonary disease | National Jewish Health | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-10-07 | AstraZeneca | Results Airsupra demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial astrazeneca.com ↗
Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis |
| 2023-01-11 | AstraZeneca | Regulatory Airsupra (PT027) approved in the US for asthma astrazeneca.com ↗
Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. |
| 2021-09-09 | AstraZeneca | Results Fixed-dose combination of albuterol and budesonide (PT027) demonstrated significant benefits for asthma patients in MANDALA and DENALI Phase III trials astrazeneca.com ↗
The DENALI trial met the dual primary endpoints, with PT027 showing a statistically significant improvement in lung function measured by forced expiratory volume in one second (FEV1), compared to the individual components albuterol and budesonide, and compared to placebo. |
| 2020-06-24 | AstraZeneca | Results Breztri Aerosphere significantly reduced rate of moderate or severe COPD exacerbations in Phase III ETHOS trial astrazeneca.com ↗
Compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Breztri Aerosphere achieved a 24% reduction (p<0.001) in exacerbations. |
| 2019-08-28 | AstraZeneca | Results Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease astrazeneca.com ↗
At half of the budesonide dose, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 160/14.4/9.6mcg) also demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with Bevespi Aerosphere and PT009. |
| 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. |
| 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 ↗
AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. |
All press releases naming this drug 8 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 NCT01253473 ↗ |
| Route | Inhaled | “Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®)” NCT01253473 ↗ |