EMA accepts marketing authorisation application for GSK's linerixibat

(Sharecast News) - GSK said on Monday that the European Medicines Agency has accepted its marketing authorisation application for linerixibat, an investigational treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC). The FTSE 100 pharmaceuticals giant said the submission was based on data from the 'GLISTEN' phase three trial, which showed that linerixibat delivered a rapid, significant, and sustained improvement in itch severity and itch-related sleep disruption compared to placebo.

It noted that the safety profile observed in the trial was consistent with previous studies.

Linerixibat, a targeted inhibitor of the ileal bile acid transporter (IBAT), is not currently approved in any country.

It is also under regulatory review in the US and UK.

The EMA and US FDA had both granted orphan drug designation for the candidate therapy.

"The EMA acceptance of this file marks another significant step forward in the progress of linerixibat, following FDA acceptance earlier this month," said Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation research and development at GSK.

"We believe linerixibat has the potential to bring relief to patients living with relentless itch associated with PBC, a condition that often disrupts sleep, and for which there are currently few effective treatment options available."

PBC is a rare autoimmune liver disease in which disrupted bile flow can lead to a severe internal itch, known as cholestatic pruritus, that GSK said affects up to 90% of patients.

It said existing treatments for PBC often fail to address this symptom, which can significantly impair quality of life and, in some cases, lead to liver transplantation even in the absence of liver failure.

GSK said the GLISTEN study enrolled 238 patients across 19 countries and was the first truly global phase three trial for PBC.

Participants had moderate to severe itch and were assessed for both itch severity and sleep interference using numerical rating scales.

At 1049 BST, shares in GSK were up 0.36% at 1,408p.

Reporting by Josh White for Sharecast.com.