Weekly Spotlight - 14.11.24

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In the News

Ocaliva Approval Delayed by FDA for PBC Treatment

The FDA has denied full approval for Ocaliva in treating primary biliary cholangitis, citing insufficient data. However, it remains a secondary option for patients unresponsive to first-line treatments. Intercept Pharmaceuticals is committed to working with the FDA, emphasising hope for patients with limited options.

Volixibat Gains FDA Breakthrough Status for PBC Itching Treatment

Volixibat, developed by Mirum Pharmaceuticals, has received breakthrough therapy designation from the FDA for treating itching in primary biliary cholangitis (PBC) patients. This designation aims to expedite its development. Preliminary results show significant improvement in pruritus and fatigue, with mild side effects. Completion is expected by December 2025.

FDA Requests Further Studies on Obeticholic Acid for PBC Patients

The Global Liver Institute acknowledges the FDA's request for further studies on obeticholic acid for primary biliary cholangitis. While awaiting full approval, the drug remains available. The Institute supports patient involvement in research to ensure treatments are safe and effective, emphasising collaboration and patient advocacy.

Liver Disease Detected Early in NHS Screening Pilot

The NHS's innovative screening tool in Somerset has diagnosed hundreds with liver disease before symptoms appear. By analysing historical medical data, the programme identifies at-risk individuals, allowing early intervention. Patients like Brian McHugh, diagnosed with an autoimmune liver condition, benefit from timely treatment, highlighting the programme's life-saving potential.