Dive Brief:

• GSK on Friday said its Nucala medicine succeeded in a Phase 3 study of patients with chronic obstructive pulmonary disease, offering the British drugmaker another shot at an expanded approval for the drug
• The trial, known as MATINEE, included COPD patients suffering from chronic bronchitis and/or emphysema who were already taking inhaled therapies and showed evidence of a certain type of inflammation. Adding Nucala to the patients’ treatment regimens significantly reduced disease exacerbations compared with placebo, GSK said.
• Researchers followed the progress of patients in the study for as long as two years, GSK said. The company didn’t release detailed data on safety or efficacy but said the preliminary results on side effects were consistent with previous research on Nucala.

Dive Insight:

GSK initiated the new study after failing to win approval for Nucala in COPD in 2018. At the time, the Food and Drug Administration asked for more clinical data to support the expanded indication.

Nucala is a biologic therapy that targets a key messenger protein in the body called interleukin-5. It first won approval in 2015 for certain patients with severe asthma, and GSK believes it has the potential to treat a range of inflammatory conditions, including COPD.

The latest data will “inform ongoing discussions with regulatory authorities," GSK said Friday. Researchers also plan to present the results at a future medical meeting.

French drugmaker Sanofi and its partner Regeneron Pharmaceuticals are also trying to introduce a new treatment option in the COPD market. The companies’ blockbuster Dupixent drug showed promise in two late-stage studies of patients with the condition last year. They expect an answer from the FDA on their application for expanded approval of the medicine by Sept. 27, after a three-month delay.

More than 300 million people around the world suffer from COPD, with about 40% exhibiting the type of inflammation affecting patients in GSK’s latest trial, according to the company. The disease can cause lung damage that leads to hospitalizations and a higher risk of death.