GlaxoSmithKline’s Nucala (mepolizumab) could help the London-based drugmaker maintain its edge in the respiratory disease treatment space.
GSK announced new data showing that the biologic used as an add-on to standard of care achieved both primary and secondary endpoints by producing clinically and statistically significant improvements in quality of life and lung function for patients diagnosed with severe asthma driven by eosinophilic inflammation.
An estimated 5 to 10 percent are diagnosed with this severe form of asthma, which involves an over-production of white blood cells called eosinophils that initiate lung inflammation boosting the frequency of asthma attacks.
This particular form of the disease is the most difficult to treat.
This phase3b analysis involved 551 patients treated with a 100mg subcutaneous injection of Nucala, which was administered every four weeks for a 24 week period.
Investigators evaluated the drug’s impact based on results from the St. George’s Respiratory Questionnaire (SGRQ), a metric used to assess how severe asthma symptoms affect a patient’s quality of life from a social and physiological perspective, and observersations regarding lung function using the pre-bronchodilator FEV1 as a way to measure how much air these patients could forcefully blowout of their lungs as well as analyzing breathing improvements.
The SQRQ scores revealed Nucala improved quality of life by 7.7 units compared to baseline versus placebo after 24 weeks. Findings from the FEV1 part of trial indicated lung function increased by 120mL more than placebo patients at the culmination of the testing period.
Furthermore, researchers used these measures to track progress throughout the study where they found sustained improvements began after the first four weeks.
“The data from the MUSCA study underscore the importance of Nucala as a treatment option for patients with severe asthma with an eosinophilic phenotype. These are patients who have very limited treatment options to control their asthma. For them shortness of breath, wheezing, coughing and the risk of an asthma attack is an ever present occurrence and one that can have a severe impact their life on a daily basis,” said GSK’s medical affairs lead Dr. Frank Albers, in a statement.
“By demonstrating improvements in a range of important markers of asthma control, including quality of life and lung function, these data reinforce the valuable role Nucala can play in the treatment of some of the most severe asthma patients,” continued Albers.
Nucala’s safety data was in line with previous studies, but its strong efficacy profile could help GSK stave off possible generic competition against top-selling asthma therapy Advair.
Researchers presented this information on Monday at the annual American Academy of Allergy, Asthma & Immunology (AAAAI) meeting in Atlanta, Georgia.
Filed Under: Drug Discovery
