Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. FDA label
Symbicort · 3 trials · 2 indications
The annual COPD exacerbation rate was analyzed and compared between two arms. Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years. The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model. Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations. Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics. Severe exacerbation: symptoms that require hospitalization (including \>24 hours in ED/urgent care setting).
Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
| Arm | Type | Description |
|---|---|---|
| Symbicort pMDI | ACTIVE_COMPARATOR | Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation |
| Formoterol Turbuhaler | ACTIVE_COMPARATOR | Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation |
| 1 Symbicort/inhaler | ACTIVE_COMPARATOR | Symbicort BA MDI 2x160/4.5 μg twice daily |
| Symbicort/inhaler | ACTIVE_COMPARATOR | Symbicort AC pDMI 2x160/4.5 μg twice daily |
| Budesonide/inhaler | ACTIVE_COMPARATOR | Budesonide AC pMDI 2x160 μg twice daily |
| Name | Type | Description |
|---|---|---|
| Symbicort | DRUG | Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses |
| Formoterol turbohaler | DRUG | Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses |
| Placebo for Symbicort pMDI | OTHER | pMDI, aerosol for oral inhalation, placebo, 120 doses |
| Placebo for Formoterol Turbohaler | OTHER | PLacebo powder for oral inhalation, 60 doses |
| Budesonide | DRUG | Actuation counter pressured metered dose inhaler |
| Symbicort, used twice daily (b.i.d) and as needed (prn) | DRUG | - |
| Budesonide Turbuhaler 200 µg | DRUG | - |
| Fluticasone Discus 250 µg | DRUG | - |
| Formoterol Turbuhaler 4.5 µg | DRUG | - |
| Terbutaline Turbuhaler 0.5 mg | DRUG | - |
| Salbutamol pressurized metered dose inhaler (pMDI) 100 µg | DRUG | - |
| Salmeterol Discus 50 µg | DRUG | - |
| Budesonide/Formoterol Turbuhaler 160/4.5 µg | DRUG | - |
| Fluticasone/Salmeterol Discus 250/50 µg | DRUG | - |
| Fluticasone/Salmeterol Discus 500/50 µg | DRUG | - |
| Theophylline 200 mg | DRUG | - |
| Theophylline 300 mg | DRUG | - |
| Singulair 10 mg | DRUG | - |
Inclusion Criteria: 3\. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines. 4\. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year). 5\. Post-bronc...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Symbicort is used to treat asthma and chronic obstructive pulmonary disease (COPD). It is a small molecule therapy developed by AstraZeneca PLC. Clinical trials have studied it in adults and adolescents with persistent asthma and in COPD patients aged 40 years and older.
Symbicort is developed and manufactured by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company has sponsored Phase 3 clinical trials of the therapy in both asthma and COPD patient populations across multiple countries.
Symbicort has been studied in Phase 3 clinical development. Its trials are listed as completed, including a 2,026-patient COPD exacerbation study and two asthma studies. The program includes both active-controlled and randomized, double-blind trial designs.
Symbicort has been evaluated in completed Phase 3 trials including NCT02157935, which compared Symbicort pMDI with formoterol Turbuhaler in 2,026 COPD patients, NCT01360021, which studied a breath-actuated inhaler in 214 asthma patients, and NCT00252863, which compared single inhaler therapy with conventional best practice in 1,600 adults with persistent asthma.