On March 14th, the U.S. Food and Drug Administration (FDA) approved a new drug to be used to help patients with liver scarring (fibrosis) as a result of nonalcoholic steatohepatitis.
In an article published by CNN Katherine Dillinger describes what nonalcoholic steatohepatitis (NASH) is more in depth, writing that it is “an advanced form of nonalcoholic fatty liver disease” which occurs “when the liver becomes inflamed because of excess fat cells” (March 14th).
The previously mentioned CNN article written by Dillinger writes about how exactly the new drug Rezdiffra (resmetirom) helps, saying, “The medication – which activates a thyroid hormone receptor in the liver to help reduce fat accumulation – is taken by mouth daily. It’s approved for people who have NASH with moderate to advanced fibrosis, and it’s intended to be used along with a healthy diet and exercise” (March 14th).
The FDA writes in a news release about the drugs trial, explaining that there are three groups involved in the trial, those who received a placebo, those who received 80 milligrams of Rezdiffra, and those who received 100 milligrams of Rezdiffra. Each of these were given once a day, and the subjects still participated in their normal NASH treatment, including what the article refers to as “counseling for healthy diet and exercise” (March 14th).
Writing for CNN in the previously mentioned article, Dillinger (giving The New England Journal of Medicine as her source) writes, “Clinical trial results published in February showed that more than 25% of participants taking 80 milligrams of resmetirom achieved NASH resolution with no worsening of fibrosis, as did almost 30% of those taking 100 mg and less than 10% of participants who got a placebo” (March 14th).
The FDA shares in the aforementioned news release that, “The most common side effects of Rezdiffra included diarrhea and nausea. Rezdiffra comes with certain warnings and precautions, such as drug-induced liver toxicity and gallbladder-related side effects” (March 14th). Furthermore, the FDA mentions that it “should be avoided in patients with decompensated cirrhosis” (March 14th).
In this same article, Dillinger writes that resmetirom is expected to be available next month, after the FDA gave it what is referred to as “Breakthrough Therapy designation”, which allows the reviewal of drugs to be fast tracked if they treat a serious condition and are a great improvement over other available treatments (March 14th).
