The goal of LIVMARLI is to provide lasting itch relief for patients with Alagille syndrome who are 3 months of age and older.
For many patients taking LIVMARLI, itch relief was seen at the very first assessment.* Full improvement in the itch was felt by 3 to 4 months on LIVMARLI, and this relief was maintained through the first year.
*Itch relief was first assessed at Week 3.
Patients with Alagille syndrome were treated with LIVMARLI in a 4-year clinical study. During that time, many patients taking LIVMARLI experienced significantly less itchiness.
During the first year of treatment with once-daily LIVMARLI, more than 80% of patients experienced less itchiness than they felt at the start of treatment. This means that patients had an improvement in their Itch Reported Outcome (ItchRO) score of 1 or more.
Patients who continued to take LIVMARLI after the first year (as part of the long-term part of the clinical study) experienced minimal to no itch for the vast majority of days on treatment.
Patients were treated with LIVMARLI in a 4-year clinical study. The purpose of the study was to find out if LIVMARLI helped reduce a patient’s level of itch.
In the clinical study, patients kept an ongoing log of their itch using the Itch Reported Outcome (ItchRO) tool. This tool was used to measure itch severity over time based on a 5-point scale:
Changes in ItchRO score by 1 point or more represent noticeable differences in the itch; for example, a change from 3 to 2 means that a patient went from feeling very itchy to feeling somewhat itchy.
Some patients with Alagille syndrome continued taking LIVMARLI during 3 long-term clinical studies.
Patients who experienced a significant improvement in their itch were also more likely to experience transplant-free survival, meaning that they were alive and did not have a liver transplant.
For those who achieved more than a 1-point reduction in ItchRO(Obs), 93% were alive and did not have a transplant 6 years after starting LIVMARLI.†
Unmanageable itch was a common reason for liver transplant in many patients with Alagille syndrome.
†The impact of LIVMARLI medicine on transplant-free survival has not been established. No information about liver fibrosis (scarring) was collected.
There were 3 clinical studies conducted for patients with Alagille syndrome. Some patients from those studies chose to stay on LIVMARLI long term. These patients were observed to see if there were any factors that could predict transplant-free survival.
Patients were included if they had moderate-to-severe itch, were considered to be benefitting from LIVMARLI, stayed on treatment for at least 48 weeks, and had lab results at 48 weeks. All patients took LIVMARLI.
Transplant free means patients were still alive and had not undergone a liver transplant. Transplant-free survival refers to the percentage of patients who are alive and have not gotten a liver transplant at a certain point in time.
In the clinical studies, patients kept an ongoing log of their itch using the Itch Reported Outcome (ItchRO) tool. They were then assessed to determine the relationship between their itch intensity score and transplant-free survival.
Patients used this tool to measure itch severity over time based on a 5-point scale:
So, for those who had more than a 1-point improvement in their itch—for example, going from “very itchy” to “a little bit itchy”—93% were alive with their liver after 6 years of taking LIVMARLI.
For those who had a 1-point improvement in their itch or less—for example, going from "very itchy" to "somewhat itchy"—57% were alive with their liver after taking LIVMARLI for 6 years.
Mirum Access Plus works closely with your doctor and insurance plan to help facilitate coverage for LIVMARLI.
Get the conversation started about whether LIVMARLI is right for you or your child.
LIVMARLI is a prescription medicine used to treat cholestatic pruritus (itch) in patients who are 3 months of age and older with Alagille syndrome.
It is not known if LIVMARLI is safe and effective in children with Alagille syndrome who are under 3 months of age. It is not known if LIVMARLI is safe and effective in adults who are 65 years of age and older.
What are the possible side effects
of LIVMARLI?
LIVMARLI can cause serious side effects, including:
Tell your health care provider about all medicines that you take, as LIVMARLI may interact with other medicines. If you take a medicine that lowers cholesterol by binding bile acids, such as cholestyramine, colesevelam, or colestipol, take LIVMARLI at least 4 hours before or 4 hours after you take that medicine.
Your health care provider may change your dose, or temporarily or permanently stop treatment if you have certain side effects.
LIVMARLI is available in oral solution and tablet formulations. LIVMARLI is taken by mouth, 1 time each day, 30 minutes before a meal in the morning. For the oral solution, be sure to use the provided oral dosing dispenser to accurately measure the dose of medicine.
These are not all of the possible side effects of LIVMARLI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information and Instructions for Use, for LIVMARLI.