Thrilled to see the approval of Linerixibat to treat moderate to severe cholestatic pruritus (intense itching) in adult patients with Primary Biliary Cholangitis (PBC).
This approval addresses a significant unmet need in cholestatic pruritus associated with Primary Biliary Cholangitis and provides a new avenue for adult patients for whom effective, targeted therapies were previously unavailable.
Mechanism:
Linerixibat inhibits IBAT in the intestine, reducing bile acid reuptake. Thereby, increased fecal excretion of bile acids occurs, blocking bile acid build-up. Reduced serum bile acids alleviate pruritus (itch) associated with Primary Biliary Cholangitis (PBC), a condition caused by bile acid accumulation.
Why is it better than already available options?
Cholestyramine is the only licensed option for hepatic pruritus; Rifampicin, Naltrexone, and Sertraline were used off-label, all associated with significant side effects and limited efficacy.
Linerixibat is now the first drug specifically approved for cholestatic pruritus in PBC in the US, offering relief as early as Week 2.
Cholestatic pruritus disturbs sleep badly in PBC patients, Linerixibat significantly improved sleep quality, making a meaningful difference in patients’ day-to-day lives.
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What are your thoughts on the impact of this new therapy on the current standard of care?
people who have PBC often suffer from intense itching. The medicines which already use don’t always relieve these symptoms properly. but this drug is helpful because it can better control the severe itching when other fail.
Interesting development. I have seen patients with intense itching and their urge to scratch themselves till the skin peels off. But the concern here is the 61% diarrhea, which is very significant very patients already with chronic liver conditions.
Yes, you’re right but according to GLISTEN phase 3 clinical trial: the severity of diarrhea was mild-moderate, and also the discontinuation due to diarrhea was as low as 4%. @Bhas_B
Cholestatic pruritis associated with Primary Sclerosing Cholangitis can be debilitating in patients affecting their lifestyle and sleep. I think this drug will immensely benefit patients.
New drug evolution definitely has to be there to improve the existing formulations or replace the old ones with ones having better overall activity and for improving the therapeutic effects.
