Written by Amal Allam
Saturday, March 16, 2024 08:59 AM
The US Food and Drug Administration (FDA) has approved a drug to treat adults with non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), for use in combination with diet and exercise.
Previously, patients with non-alcoholic steatohepatitis who also had significant scarring of the liver did not have a drug that could treat cirrhosis, said Nikolai Nikolov, acting director of the Office of Immunology and Inflammation at the FDA’s Center for Drug Evaluation and Research. Directly, he explained, “The approval of the drug will provide, for the first time, a treatment option for these patients, in addition to diet and exercise.”
According to the US Food and Drug Administration (FDA) website, non-alcoholic steatohepatitis is the result of the development of non-alcoholic fatty liver disease, where inflammation of the liver can lead, over time, to scarring of the liver and impaired liver function. Non-alcoholic steatohepatitis is often associated with With other health problems such as high blood pressure and type 2 diabetes, according to at least one estimate, approximately 6 to 8 million people in the United States have non-alcoholic steatohepatitis with moderate to advanced liver scarring, and this number is expected to rise. The drug is considered a partial activator of thyroid hormone receptors. Activation of this receptor by Resdivira in the liver reduces the accumulation of fat in the liver.
The safety and efficacy of the drug were evaluated based on surrogate endpoint analysis at month 12 in a 54-month randomized, double-blind, placebo-controlled trial. The surrogate endpoint measured the extent of liver inflammation and scarring. The sponsor is required to conduct a post-approval study to verify and describe the clinical benefits of the drug, which will be conducted through completion of the same 54-month study, which is ongoing. To enroll in the trial, patients need to have a liver biopsy showing inflammation due to NASH with moderate or advanced liver scarring. In the trial, 888 people were randomly assigned to receive one of the following: placebo (294 people); 80 milligrams of rosehip (298 items); or 100 milligrams of the drug (296 items); Once daily, in addition to standard care for NASH, which includes counseling on a healthy diet and exercise.
After 12 months, liver biopsies showed that a greater proportion of people treated with the drug achieved resolution of NASH or improvement in liver scarring than those who received a placebo. A total of 26% to 27% of people who received 80 milligrams of the drug and 24% to 36% of people who received 100 milligrams experienced resolution of nonalcoholic steatohepatitis and no worsening of liver scarring, compared with 9% to 13% of those who took He received a placebo and advice on diet and exercise. The range of responses reflects different readings of pathologists. In addition, a total of 23% of people who received 80 milligrams and 24% to 28% of people who received 100 milligrams of the drug saw improvement in liver scarring and no worsening of nonalcoholic steatohepatitis, compared with 13% to 15% of people who did not. They received 100 milligrams of the drug. Those who received a placebo, based on each pathologist’s readings. It is noteworthy that these changes were demonstrated in a proportion of patients after only one year of treatment, as the disease usually progresses slowly with the majority of patients taking years or even decades to show progression.
The most common side effects of the drug include diarrhea and nausea. The drug comes with certain warnings and precautions, such as drug-induced liver toxicity and gallbladder-related side effects.
According to the American Drug Administration, the use of the drug should be avoided in patients suffering from decompensated cirrhosis. Patients should stop using Resdevra if they develop signs or symptoms of worsening liver function during treatment.
Using the drug at the same time as certain other medications, especially statins used to lower cholesterol, may lead to potentially significant drug interactions. Healthcare providers should consult the full prescribing information for additional information about these potential drug interactions of interest with the drug, recommended dosage and administration adjustments.
The US Food and Drug Administration approved the drug under the accelerated approval pathway, which allows early approval of drugs that treat serious conditions and address unmet medical needs, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit, the required study mentioned above and which It lasts for 54 months, which is ongoing, and will evaluate clinical benefit after 54 months of treatment.
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