The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead Sciences Inc.’s (NASDAQ: GILD) Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. This approval marks a significant step forward in the treatment options available for patients suffering from this chronic liver disease.
Seladelpar: PPAR-Delta Agonist
Seladelpar, a PPAR-delta agonist originated by US biotech CymaBay Therapeutics Inc., was acquired by Gilead in February of last year via a USD 4.3 billion M&A deal. In clinical trials, seladelpar demonstrated significant improvements in liver function, with 62% of patients experiencing normalization of alkaline phosphatase (ALP) levels and reduced itching. These results highlight the potential of seladelpar to address key symptoms and improve outcomes for patients with PBC.
US Approval and Global Expansion
Livdelzi was previously approved in the US in August of last year, paving the way for its global expansion. The MHRA’s approval in the UK further solidifies Gilead’s position in the market for treatments targeting primary biliary cholangitis. This approval is expected to enhance access to Livdelzi for patients in need, offering a new therapeutic option to manage this challenging condition.-Fineline Info & Tech
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