TEL AVIV Teva Pharmaceutical Industries said a drug under development had positive results in reducing the frequency of clinical asthma exacerbations in two advanced trials in patients with moderate to severe asthma.
Reslizumab, an investigational antibody, showed statistically significant reductions in the frequency of asthma exacerbations - episodes of progressively worsening shortness of breath, coughing, wheezing, and chest tightness - compared to patients taking a placebo in both Phase III studies, Israel based Teva said on Tuesday.
Reslizumab also demonstrated a positive effect on lung function and asthma control, Teva said, noting the data will be presented at the European Respiratory Society Congress next week.
Michael Hayden, president of research and development and chief scientific officer at Teva, said the company planned to submit applications for approval as soon as possible. Regulatory submission is planned for the first half of 2015 in the United States, followed by the European Union and other regions.
Teva said the market for severe asthma biotech drugs could exceed $7.5 billion a year in the United States and Europe.
"The success of these studies gives us confidence that we may have a valuable potential new treatment option for asthma patients, with elevated levels of blood eosinophils, who are at risk of exacerbation." Hayden said.
Increased levels of eosinophils, white blood cells associated with allergy and asthma, have been shown to correlate with future risk and severity of asthma exacerbations.
The two Phase III studies involved 953 patients across 232 medical centers in the United States, European Union and Asia.
Further analyses of additional efficacy and safety data continued, Teva said.
Reslizumab is administered intravenously once every four weeks. A subcutaneous form of administration is also under development.
(Reporting by Tova Cohen)