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American authorities have authorized the first treatment for non-alcoholic fatty liver disease (NASH), better known as “fatty liver disease”. Hope in the face of a constantly growing pathology which affects between 25 and 30% of the population.
“Fatty liver disease”, a growing pathology
NASH is caused by the accumulation of fat in the liver linked to poor eating habits and a sedentary lifestyle. It reflects inflammation of the liver which, over time, can lead to liver scarring and liver dysfunction with serious complications: cirrhosis, liver failure and liver cancer. It is often associated with other health problems such as high blood pressure and type 2 diabetes. It will soon be the leading cause of liver transplants. It is estimated that between 25 and 30% of the population would be affected.
Today, only weight loss is recommended, through a change in lifestyle (healthy diet, blood sugar control and physical activity). For obese people with comorbidities, bariatric surgery also improves NASH and liver fibrosis. But in the United States, a drug has just been authorized with this indication, the first to treat this disease.
First drug indicated for NASH
The new drug, resmetirom from Madrigal Pharmaceuticals, will be marketed under the brand name Rezdiffra. The medication activates a thyroid hormone receptor in the liver to help reduce fat accumulation. It must be taken orally daily. In the United States, it was just approved for people with NASH with moderate to advanced fibrosis, and it is intended to be used in combination with a healthy diet and exercise.
The results clinical trials published in February showed that more than 25% of participants taking 80 milligrams of resmetirom achieved resolution of NASH without worsening fibrosis, as did nearly 30% of those taking 100 mg and just 10% of participants who received a placebo. Additionally, 23% of patients who received 80 milligrams of Rezdiffra and 24% to 28% of subjects who received 100 milligrams of Rezdiffra experienced improvement in liver scarring and no worsening of NASH, compared with 13% to 15% of those who received 100 milligrams of Rezdiffra. received a placebo. “Demonstrating these changes in a proportion of patients after only one year of treatment is remarkable, as the disease generally progresses slowly and the majority of patients take years or even decades to show progression.” specifies FDA press release.
Most reported side effects were mild or moderate: diarrhea and nausea were the most common. However, the medication may have interactions.potentially significant” with certain other drugs, including statins commonly used to lower cholesterol, according to the FDA.
Studies continue on potential long-term benefits
We do not yet know how many patients will benefit from this treatment, but it constitutes a first drug for these patients, as underlines the Madrigal Pharmaceuticals laboratory whose shares benefited greatly from this authorization to place it on the American market. According to Stephen Harrison, hepatologist and lead author of the Maestro study on the effectiveness of resmetirom: “Based on the strong efficacy and safety data generated in two large Phase 3 MAESTRO studies, I believe that Rezdiffra will become the cornerstone treatment for patients with NASH with moderate to advanced liver fibrosis (…) It is important to note that we continue to study Rezdiffra to determine whether the positive results observed in the MAESTRO studies will result in a reduced risk of progression to cirrhosis, liver failure, need for liver transplantation, and premature mortality“.