Approval Probability
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Adjusted LOA
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BFF MDI 160/9.6 μg · 1 trial · 1 indication
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
| Arm | Type | Description |
|---|---|---|
| BFF MDI 160/9.6 μg BID (320/19.2μg/day) | EXPERIMENTAL | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | ACTIVE_COMPARATOR | Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) |
| Name | Type | Description |
|---|---|---|
| BFF MDI 160/9.6 μg BID (320/19.2μg/day) | DRUG | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | DRUG | Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) |
Inclusion Criteria 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females of childbearing potential should be using highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines \[GIN...
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 |
BFF MDI 160/9.6 μg is an investigational metered dose inhaler combining budesonide and formoterol fumarate, developed by AstraZeneca PLC for the treatment of asthma. It is a small molecule combination product delivered by inhalation and is being studied in patients whose asthma is not adequately controlled.
BFF MDI 160/9.6 μg is being developed to treat asthma in patients whose symptoms remain inadequately controlled. The Phase 3 LITHOS study evaluated the combination inhaler in participants aged 12 years and older with inadequately controlled asthma, comparing it against budesonide metered dose inhaler.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of BFF MDI 160/9.6 μg. The company is responsible for the clinical development of the budesonide and formoterol fumarate metered dose inhaler in asthma.
BFF MDI 160/9.6 μg is in Phase 3 development. Its single Phase 3 trial, LITHOS, has been completed. The asset is investigational and is not approved for commercial use; it remains in clinical development for asthma.
BFF MDI 160/9.6 μg has been studied in the Phase 3 LITHOS trial, registered as NCT05755906. That randomized, double-blind, active-controlled study enrolled 374 participants with inadequately controlled asthma across the United States, Canada, Czechia, Malaysia, Philippines, South Africa, South Korea, and it has completed.