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Highlights
GSK submits application to the European Medicines Agency for linerixibat in treating pruritus in PBC
EMA decision follows earlier FDA acceptance for the same treatment
Phase III results presented at the EASL Congress showed consistent clinical benefits
GSK (LON:GSK), a leading biopharmaceutical firm listed on the FTSE 100, operates in the healthcare sector with a diverse pipeline focused on immunology, infectious diseases, and oncology. The company has confirmed that the European Medicines Agency (EMA) has accepted the marketing authorization application for linerixibat, a drug developed for addressing pruritus associated with primary biliary cholangitis (PBC), a rare liver condition.
The EMA’s acceptance comes shortly after the United States Food and Drug Administration also agreed to evaluate the same treatment earlier in the month. This dual progress marks a notable step in GSK’s development efforts, particularly within its liver disease segment.
Positive Clinical Trial Outcomes Presented at EASL
The application submitted to EMA is backed by data from a pivotal Phase III clinical trial, which was disclosed during the recent EASL Congress. The trial met all of its primary and secondary clinical endpoints. Patients reported a sustained reduction in pruritus severity, as well as improvements in sleep quality — both of which are crucial indicators in evaluating treatment impact in PBC cases.
The study results highlighted the rapid onset of clinical benefit with linerixibat, reinforcing its therapeutic relevance. These outcomes were presented to an international audience of hepatology experts, adding scientific visibility to the findings and underscoring the clinical significance of the drug.
Focused Approach to Address Unmet Needs in PBC
Primary biliary cholangitis is a chronic autoimmune condition that leads to progressive liver damage. A persistent symptom of this condition is pruritus, which significantly affects patients' quality of life. GSK's linerixibat aims to address this through selective inhibition of the ileal bile acid transporter (IBAT), a novel mechanism of action that may offer relief where few options currently exist.
The treatment has been designated for patients who experience moderate to severe itching despite existing therapies. GSK’s development of linerixibat fits within its broader strategy to deliver innovative treatments for diseases with substantial unmet clinical needs.
Broader Pipeline and Regulatory Strategy
The progression of linerixibat through both European and US regulatory systems reflects GSK's integrated global strategy in new drug approvals. The company continues to prioritize therapies that align with long-term growth in specialty care markets.
Alongside other assets in its pipeline, linerixibat reinforces GSK’s scientific in hepatology and chronic disease management. As part of the FTSE 100 and FTSE 350 indices, the company maintains a significant presence in the UK market, with ongoing commitments to research, innovation, and treatment development.
Dividend Relevance
GSK is also tracked under the FTSE Dividend Stocks, which highlights its profile among UK-listed firms known for consistent dividend distributions. This reflects its financial stability and longstanding return practices within the healthcare industry.
