GSK's Nucala Approved for COPD, Challenges Sanofi's Dupixent

GlaxoSmithKline (GSK) has secured approval from the U.S. Food and Drug Administration (FDA) for its drug Nucala, intensifying the competition with rival Sanofi's Dupixent. The FDA has approved Nucala as an adjunctive treatment for certain patients with chronic obstructive pulmonary disease (COPD), a leading cause of death globally. COPD is a life-threatening inflammatory respiratory disease that causes airflow obstruction.

Sanofi and Regeneron Pharmaceuticals were the first to bring Dupixent to market, addressing a long-standing gap in COPD treatment options that had persisted for over a decade. The approval of Nucala provides COPD patients with an additional therapeutic option, complementing existing treatments such as inhalers, corticosteroids, and specialized exercise programs.

GSK estimates that the approval of Nucala for COPD treatment could generate approximately 5 billion pounds (6.7 billion USD) in peak annual sales. Previously, Nucala had been approved for treating conditions including severe asthma. Analysts have noted that the latest data from a late-stage trial indicates that Nucala will compete directly with Dupixent. Both Nucala and Dupixent are biologic drugs that offer more treatment choices for COPD patients, who have traditionally relied on inhalers, corticosteroids, and specialized exercise programs.

The market dynamics will likely involve efforts to compare the two drugs, but given the limited alternatives, both are expected to gain significant market recognition. Nucala is administered via injection every four weeks, while Dupixent requires injections every two weeks. GSK's Chief Commercial Officer, Luke Miels, has acknowledged the intense competition between Nucala and Dupixent. He mentioned that GSK has been closely monitoring the market entry of Dupixent, including Sanofi's market access, patient base, and the reasons for its use.

Miels also expressed caution regarding the initial sales of Nucala, noting that the drug will primarily be prescribed by pulmonologists for COPD treatment. These specialists will recommend biologic drugs to a select group of patients, and there will be a period of experimentation, application, and training. This approval marks a significant milestone for GSK, as it expands its portfolio in the respiratory disease treatment sector and positions Nucala as a key player in the competitive landscape against Sanofi's Dupixent.