Ursodeoxycholic acid

EMA's CHMP recommended Gilead Sciences' seladelpar for EU approval as a second-line PBC treatment, either with UDCA or alone for non-UDCA responders/intolerants. The European Commission is expected to decide by early 2025. Seladelpar, already U.S.-approved as Livdelzi, targets PPAR-delta to manage liver inflammation and symptoms like itching, based on Phase 3 RESPONSE trial data showing significant improvement in liver damage markers and itch relief. An ongoing Phase 3 AFFIRM trial tests its efficacy in PBC patients with compensated cirrhosis.

FDA identified serious liver injury risk in PBC patients without cirrhosis taking Ocaliva, with higher liver transplant risk compared to placebo. The drug is contraindicated for advanced cirrhosis patients, but some still received it. FDA urges frequent liver tests and discontinuation if signs of progression or lack of efficacy.

Approval of ursodeoxycholic acid (UDCA) in 1997 significantly reduced liver transplant and death risks for primary biliary cholangitis (PBC), but up to 40% of patients do not sufficiently respond. Off-label use of fibrates and the 2016 approval of obeticholic acid (Ocaliva) as a second-line treatment provided additional options, though Ocaliva has downsides like increased pruritus. New PPAR agonists, seladelpar and elafibranor, have been approved for PBC, showing potential benefits but with unknown long-term risks.

Advanz Pharma's Ocaliva (obeticholic acid) for PBC loses EU market access as EC revokes conditional marketing authorisation, leaving limited second-line options for patients. Advanz CEO criticizes court's ruling for not assessing patient impact. Ocaliva remains available in the US under accelerated approval.

Elafibranor treatment for primary biliary cholangitis (PBC) showed no impact on renal function markers in the ELATIVE study, with stable median levels of cystatin C, serum creatinine, and estimated glomerular filtration rate through week 52, indicating no safety signal for renal toxicity.

Sunshine Biopharma launches Ursodiol, a generic prescription drug for cholestatic liver diseases and gallstone treatment, through its Canadian subsidiary Nora Pharma. The global Ursodiol market is projected to grow from $457.9M in 2022 to $933.9M by 2029, with a 10.7% CAGR. This marks the company's third product launch in 2023 in the Canadian generic drugs market, estimated at $9.7B in 2023 and expected to reach $19.2B by 2032.

Sunshine Biopharma launches Ursodiol, a generic drug for cholestatic liver diseases and gallstones, in Canada. The company plans to introduce 31 more drugs by 2025 and is engaged in proprietary drug development. Recent financial metrics show revenue growth but ongoing losses, reflecting a focus on market expansion.

Sunshine Biopharma's subsidiary, Nora Pharma, launches Ursodiol, a generic drug for cholestatic liver diseases and gallstone management, available in 250 mg and 500 mg tablets in Canada. The global Ursodiol market is projected to grow significantly, reaching $933.9 million by 2029.

Gilead Sciences announces 81% of PBC patients achieve durable biochemical response with Livdelzi by Month 30, with 41% achieving ALP normalization. Livdelzi also reduces pruritus severity, with 27% near resolution in moderate to severe cases. The safety profile remains robust, with no treatment-related SAEs reported.

FDA declined full approval for obeticholic acid (Ocaliva) in treating primary biliary cholangitis (PBC), citing unfavorable benefit-risk profile. Intercept Pharmaceuticals will collaborate with the FDA on next steps, while the drug remains on the market. European Commission revoked obeticholic acid's marketing authorization for PBC in September.