GSK's Nucala Wins COPD Case; Dupixent Awaits FDA Decision

GSK’s respiratory drug Nucala has achieved a promising milestone, with recent trial results showcasing its potential in treating chronic obstructive pulmonary disease (COPD). On Friday, GSK announced that its IL-5 antibody, Nucala, combined with inhaled maintenance therapy, successfully reduced the annualized rate of moderate or severe exacerbations in COPD patients over a span of up to two years. This outcome is part of the MATINEE trial, which compared Nucala to a placebo and met its primary endpoint.

Though GSK has yet to present detailed data, it intends to share comprehensive study results at an upcoming medical conference. These findings are expected to support ongoing discussions with regulatory authorities regarding a potential label expansion for Nucala.

Nucala, which first received FDA approval in 2015 for severe asthma, has since been approved for multiple respiratory conditions, including Churg-Strauss Syndrome, severe eosinophilic asthma, and chronic rhinosinusitis with nasal polyps. The drug now targets a significant opportunity in COPD, a condition that GSK estimates affects more than 300 million people globally. Up to 40% of COPD patients exhibit type 2 inflammation, characterized by elevated blood eosinophil counts, which can exacerbate the disease, leading to lung damage, declining lung function, and increased hospitalization risk. GSK believes that Nucala, which targets IL-5—a key protein in type 2 inflammation—could benefit many of these patients.

The MATINEE trial is one of three ongoing studies investigating Nucala's efficacy in COPD. It involved patients with a broad range of chronic bronchitis and/or emphysema, all of whom were already on inhaled maintenance therapy and exhibited type 2 inflammation.

COPD, which hinders airflow and causes breathing difficulties, is a major cause of death in the U.S., primarily due to smoking, although nonsmokers can also develop the disease. Nucala has become the centerpiece of GSK's respiratory portfolio, generating £1.65 billion ($2.2 billion) in 2023. In the second quarter of 2024 alone, the antibody brought in £482 million ($635.7 million), marking a 17% increase from the same period the previous year.

GSK's renewed focus on Nucala in COPD follows a setback in 2018 when the FDA denied approval for the drug in this indication, aligning with an advisory panel's concerns about insufficient data. This decision concluded a competitive race in COPD between Nucala and AstraZeneca’s IL-5 antibody Fasenra, which had also failed in phase 3 trials for COPD that year. While Fasenra's development for COPD stalled, AstraZeneca has found success with other treatments, such as the triple combination inhaled corticosteroid Breztri, approved by the FDA for COPD maintenance in 2020.

Earlier this year, AstraZeneca and Amgen reported mixed results for their asthma drug Tezspire in COPD. Although the phase 2a COURSE study did not meet its primary endpoint, the drug showed efficacy in certain COPD patients.

As GSK strengthens Nucala’s case for COPD, Sanofi and Regeneron’s Dupixent faced a delay in FDA approval for COPD, with a decision now expected by September 27. This delay came after the FDA requested additional data from trials evaluating Dupixent for a potential COPD label expansion. Despite this, the European drug regulator has recommended Dupixent for COPD treatment.

Additionally, Verona Pharma received FDA approval in June for its COPD maintenance treatment, Ohtuvayre (ensifentrine), marking the first new inhaled COPD product with a novel mechanism of action in over 20 years. Verona expects to launch the drug in the U.S. market in the third quarter through specialty pharmacies.

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