Introduction to Brovana
Brovana, also known as arformoterol tartrate, is a long-acting beta-2 adrenergic agonist (LABA) used in the treatment of chronic obstructive pulmonary disease (COPD). It is administered as an inhalation solution to help control symptoms and improve lung function in patients with moderate to severe COPD.
Clinical Trials and Efficacy
One-Year Non-Inferiority Trial
A significant clinical trial conducted by Sunovion Pharmaceuticals Inc. evaluated the safety and efficacy of Brovana over a one-year period. This non-inferiority trial involved 841 patients with moderate to severe COPD, comparing Brovana to a placebo. The results showed that patients treated with Brovana experienced fewer serious respiratory events, such as COPD-related hospitalizations and respiratory deaths, compared to those receiving the placebo. Specifically, 40 out of 420 patients treated with Brovana experienced at least one serious respiratory event, whereas 63 out of 421 patients in the placebo group had such events. The mean time to the first event was longer for Brovana patients (171.7 days) than for those on placebo (155 days)[1].
Symptom Control and Lung Function
Clinical studies have demonstrated that Brovana effectively controls COPD symptoms and improves lung function. It was shown to increase the forced expiratory volume in one second (FEV1) by about 11% compared to a placebo, indicating improved airway function. Additionally, Brovana started to open airways approximately 6.7 minutes after administration and maintained this effect for more than 12 hours[4].
Market Analysis
Promotional Activities and Physician Engagement
Sunovion's promotional activities for Brovana have been extensive. Reports from 2016 and 2019 detail the company's efforts in reaching physicians through various promotional channels, including sales rep detailing, physician education, and paid speaking engagements. In 2019, over 4,900 paid interactions were made with approximately 2,000 physicians, highlighting the depth of Sunovion’s promotional efforts. These activities varied across different specialties such as pulmonology, family medicine, internal medicine, and critical care medicine[2][5].
Market Impact of Generic Version
The approval of the generic version of Brovana in April 2020 has significantly impacted its market share. Since then, the generic form of arformoterol tartrate has become a more cost-effective alternative, leading to a decline in Brovana's market share. This shift is part of a broader trend where generic drugs often capture a substantial portion of the market once they become available[3].
Market Projections and Future Landscape
COPD Market Growth
The COPD market is expected to grow significantly, driven by an increase in prevalent cases, ongoing clinical research, and improved diagnostic tools. DelveInsight estimates that the COPD market size in the 7 major markets (7MM) will grow from $16 billion in 2023 to a higher figure by 2034, with a compound annual growth rate (CAGR) of 5%[3].
Emerging Therapies
The COPD treatment landscape is poised for significant changes with the emergence of new therapies. For example, the FDA's expansion of DUPIXENT's approved uses to include COPD treatment marks a significant shift. DUPIXENT has shown a 30% reduction in moderate-to-severe exacerbations and significant improvements in lung function and quality of life. Other potential drugs in mid-stage development, such as itepekimab, benralizumab, and tezepelumab, are expected to further transform the market[3].
Competitive Landscape
The COPD market is highly competitive, with various LABA and LAMA (long-acting muscarinic antagonist) combinations available. Brovana faces competition from other LABA drugs like Serevent and Striverdi Respimat, as well as LAMA drugs such as Spiriva and Tudorza Pressair. The discontinuation of certain drugs like Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler in the US has also reshaped the market dynamics[3].
Key Takeaways
- Clinical Efficacy: Brovana has been shown to reduce serious respiratory events and improve lung function in patients with COPD.
- Market Impact: The introduction of a generic version has reduced Brovana's market share.
- Market Growth: The COPD market is projected to grow significantly due to increasing prevalence and new therapies.
- Competitive Landscape: Brovana competes with other LABA and LAMA drugs, and the market is expected to be influenced by emerging therapies.
FAQs
What is Brovana used for?
Brovana is used to treat symptoms of chronic obstructive pulmonary disease (COPD) by helping to control breathing difficulties and improve lung function.
How effective is Brovana in clinical trials?
Brovana has been shown to increase FEV1 by about 11% compared to a placebo and to reduce the risk of serious respiratory events in patients with COPD.
What is the impact of the generic version of Brovana on its market share?
The approval of the generic version of Brovana in April 2020 has led to a decline in its market share as the generic form is a more cost-effective alternative.
How is the COPD market expected to grow?
The COPD market is expected to grow from $16 billion in 2023 to a higher figure by 2034, with a CAGR of 5%, driven by increasing prevalence and new therapies.
What are some emerging therapies in the COPD market?
Emerging therapies include DUPIXENT, itepekimab, benralizumab, and tezepelumab, which are expected to transform the COPD treatment landscape.
Sources
- Sunovion Pharmaceuticals Inc. - "Sunovion Pharmaceuticals Inc. Presents Results From a One-year, Non-inferiority Clinical Trial of BROVANA® (arformoterol tartrate) Inhalation Solution" - Biospace.
- MDDetails - "Brovana 2019 U.S. PROMOTIONAL AUDIT REPORT" - MDDetails.
- DelveInsight - "Sanofi/Regeneron Pharmaceuticals' DUPIXENT Approval Marks a Significant Shift in Chronic Obstructive Pulmonary Disease Treatment Landscape" - PR Newswire.
- Medical News Today - "Brovana for inhalation: Dosage, side effects, and more" - Medical News Today.
- MDDetails - "Brovana 2016 U.S. PROMOTIONAL AUDIT REPORT" - MDDetails.
