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The U.S. Food and Drug Administration (FDA) has approved linerixibat (Lynavoy) for adults with primary biliary cholangitis (PBC). It is the first medicine approved in the U.S. specifically to treat cholestatic pruritus, a deep itch.
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In a key clinical trial, people taking linerixibat found their monthly “worst itch” score improved by about 2.86 points over 24 weeks, compared with about 2.15 points for people taking a placebo (inactive treatment).
Linerixibat is an ileal bile acid transporter (IBAT) inhibitor, a type of medicine that lowers how much bile acid is reabsorbed in the small intestine. This helps more bile acids leave the body in stool.
In PBC, bile does not flow normally from the liver, and extra bile acids in the body may contribute to itching.
The drug comes in the form of a tablet meant to be taken twice daily.
The FDA approval was based on a 24-week, randomized, double-blind, placebo-controlled trial that included 238 adults with PBC and itching.
People entered the study only if their monthly itch score during the four weeks before the study was a 4 or higher on a 0-to-10 scale. The average monthly itch score at the start of the study was about 7.3.
Linerixibat also started working early. By week 2, weekly itch scores had improved more in people taking linerixibat than in those taking the placebo.
Sleep disruption tied to itch improved as well. Over 24 weeks, people taking linerixibat had a greater reduction in their monthly sleep interference score compared to those in the placebo group.
In the main study, the most common side effects were diarrhea and abdominal (stomach) pain. Because linerixibat can reduce how well your body absorbs certain fat-soluble vitamins, your doctor may check your vitamin levels before you start treatment and during treatment. These vitamins include vitamins A, D, E, and K, and your doctor may recommend supplements if needed.
The label says linerixibat should not be used by people with severe, advanced liver disease (called decompensated cirrhosis) or certain serious liver-related complications.
Cholestatic pruritus can be more than just itching. It can disrupt sleep, make fatigue worse, and lower your quality of life, even when the rest of your PBC care is going well.
If itch is affecting your sleep or daily life, consider keeping track of when it is most severe. Bring those notes to your next hepatology or gastroenterology visit to talk about treatment options.
On myPBCteam, people share their experiences with primary biliary cholangitis, get advice, and find support.
Do you have itching with PBC? Has it affected your sleep or daily routine? Let others know in the comments below.
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