After setback, GSK's Breo gets boost from real-world data
- GlaxoSmithKline's new lung drug Breo performed better than usual care in reducing incidents of difficulty breathing among patients with chronic obstructive pulmonary disease (COPD), the company said Tuesday.
- Breo was tested in a large, real-world study of 2,800 COPD patients living in and around the U.K. city of Salford, after failing to meet its primary endpoint in another larger study back in September 2015.
- GSK aimed to prove the effectiveness of Breo in everyday use, outside of the controlled environment of clinical trials. However, the unique design and specificity to the British healthcare setting could limit the relevance of the study for the U.S. or other regulatory jurisdictions, as Reuters notes.
GSK is hoping Breo, along with its new asthma drug Nucala, can help offset the revenue loss from declining sales of its older COPD drug Advair. The company has forecast further declines through 2020 as Advair now faces generic competition in the U.S.
In the first quarter, Advair sales dropped 19% to £753 million, compared to a year ago. Still, Advair was the top-seller in GSK's respiratory business, setting a high bar for Breo and Nucala to meet - especially if sales continue to erode at as rapid a pace as in Q1.
Patients treated with Breo in the Salford lung study experienced a statistically significant reduction of 8.4% in the rate of moderate to severe exacerbations, compared to patients receiving usual care.
The randomized phase 3 trial followed patients for 12 months in normal clinical practice settings, using electronic medical records to link primary care, secondary care, and pharmacy information, the company said. Breo demonstrated a comparable incidence of serious adverse events to the standard of care.
A second, similar study is ongoing in asthma patients, with a planned read-out in 2017.
Breo combines an inhaled corticosteroid with a long-acting beta agonist to reduce inflammation and improve air flow in COPD and asthma patients. The fixed-dose drug is taken once daily using the Ellipta inhaler, also from GSK.
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