GSK's asthma drug Nucala boosted by long-term safety study
- GlaxoSmithKline's (GSK) injectable asthma drug Nucala maintained its safety profile over a longer 52-week period, the company said on Saturday. Nucala was approved by the FDA in November 2015 for patients who are non-responsive to high dose inhaled corticosteroids.
- Nucala is also being studied for use against chronic obstructive pulmonary disease (COPD).
- In further good news for GSK's asthma portfolio, a post-marketing study published in the New England Journal of Medicine showed the drugmaker's Advair Diskus had a similar safety profile to fluticasone propionate.
Nucala is intended to be used as add-on therapy in combination with other drugs, further building the arsenal of asthma medications physicians rely on to keep patients out of the hospital. More than 22 million people in the U.S. have asthma, and there are more than 400,000 asthma-related hospitalizations each year, according to Centers for Disease Control and Prevention.
Although FDA approval was based on three randomized, placebo-controlled trials, the latest safety data importantly demonstrates a sustained safety profile across the one-year mark. However, while Nucala is used to decrease the frequency and intensity of asthma exacerbations, it does not improve lung function.
Results from the 52-week trial of Nucala were presented at the American Academy of Allergy, Asthma & Immunology.