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GSK 06:01

GSK plc

Linerixibat file accepted for review by US FDA

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GSK plc has announced that the US FDA has accepted for review the New Drug Application (NDA) for linerixibat, a potential treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC). The NDA is supported by positive data from the phase III GLISTEN trial, which demonstrated the efficacy and safety of linerixibat in reducing itch and improving sleep interference. The Prescription Drug User Fee Act (PDUFA) goal date for the FDAs decision is March 24, 2026. If approved, linerixibat could address a high unmet medical need for patients with cholestatic pruritus, a debilitating symptom of PBC with limited treatment options. GSK is also investigating potential treatments for other liver diseases, including chronic hepatitis B, alcohol-related liver disease, and metabolic dysfunction-associated steatohepatitis.

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GSK 06:01

GSK plc

FDA approves Nucala COPD indication

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The US Food and Drug Administration (FDA) has approved GSKs Nucala (mepolizumab) as an additional maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, characterized by a blood eosinophil count (BEC) of 150 cells/µL or higher. This approval is based on positive results from the MATINEE and METREX phase III trials, which demonstrated a significant reduction in moderate to severe exacerbations in a diverse group of COPD patients with eosinophilic inflammation. Mepolizumab is the first and only approved biologic for COPD patients with a BEC threshold starting at 150 cells/µL, offering a new treatment option for over a million people at risk of exacerbations. COPD is a progressive inflammatory lung disease affecting over 390 million people worldwide, and Nucalas approval provides hope for improved management and prevention of exacerbations, which can lead to irreversible lung damage and worsening symptoms.

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GSK 06:01

GSK plc

Linerixibat file accepted for review by US FDA

Open AI Digest

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Return to today’s catalyst cards, chart beacons and AI charts.

GSK plc has announced that the US FDA has accepted for review the New Drug Application (NDA) for linerixibat, a potential treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC). The NDA is supported by positive data from the phase III GLISTEN trial, which demonstrated the efficacy and safety of linerixibat in reducing itch and improving sleep interference. The Prescription Drug User Fee Act (PDUFA) goal date for the FDAs decision is March 24, 2026. If approved, linerixibat could address a high unmet medical need for patients with cholestatic pruritus, a debilitating symptom of PBC with limited treatment options. GSK is also investigating potential treatments for other liver diseases, including chronic hepatitis B, alcohol-related liver disease, and metabolic dysfunction-associated steatohepatitis.

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GSK 06:01

GSK plc

FDA approves Nucala COPD indication

Open AI Digest

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Return to today’s catalyst cards, chart beacons and AI charts.

The US Food and Drug Administration (FDA) has approved GSKs Nucala (mepolizumab) as an additional maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, characterized by a blood eosinophil count (BEC) of 150 cells/µL or higher. This approval is based on positive results from the MATINEE and METREX phase III trials, which demonstrated a significant reduction in moderate to severe exacerbations in a diverse group of COPD patients with eosinophilic inflammation. Mepolizumab is the first and only approved biologic for COPD patients with a BEC threshold starting at 150 cells/µL, offering a new treatment option for over a million people at risk of exacerbations. COPD is a progressive inflammatory lung disease affecting over 390 million people worldwide, and Nucalas approval provides hope for improved management and prevention of exacerbations, which can lead to irreversible lung damage and worsening symptoms.

Go Back To AI Charts