GSK's Lung Drug Nucala Approved in U.S. for COPD, Challenging Sanofi's Dupixent

Intelligent Finance APP learned that GlaxoSmithKline (GSK.US) has received U.S. approval for a drug treating a fatal lung disease, intensifying competition with rival Sanofi (SNY.US). Reportedly, the U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline's Nucala as an add-on treatment for some patients with Chronic Obstructive Pulmonary Disease (COPD), a leading cause of death globally.

Sanofi and Regeneron Pharmaceuticals (REGN.US) were the first to bring Dupixent to market, marking the first new treatment for COPD in over a decade. COPD is a life-threatening inflammatory respiratory disease that causes airflow obstruction.

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GSK estimates that the approval of Nucala for the treatment of COPD will generate peak annual sales of approximately £500 million ($670 million). The drug was previously approved for the treatment of conditions including a severe form of asthma. John Murphy, an analyst at Bloomberg Intelligence, said in a pre-approval report that the latest data from a late-stage trial suggest Nucala will compete with Dupixent.

Biologics like Nucala and Dupixent offer more treatment options for COPD patients, who until now have mainly relied on inhalers, steroids, and specialized exercise programs.

Murphy said that marketing "will try to compare one of the drugs with another," but considering the limited alternatives, both drugs will receive "significant market recognition." Nucala is injected once every four weeks, while Dupixent is injected once every two weeks.

GSK Chief Commercial Officer Luke Miels said on the April earnings call that the company sees Nucala as competing very strongly against Dupixent. He stated that GSK has been closely monitoring the launch of Dupixent, including Sanofi's market access, patient base, and reasons why people are using the drug.

Miels said at another conference that the company was cautious about the initial sales of Nucala. The drug will mainly be prescribed by pulmonologists for the treatment of COPD, and these doctors will recommend biologics to only a small group of patients. He stated: "There will be a period of experimentation, application, and training."