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On Thursday, the Food and Drug Administration granted approval for the inaugural treatment targeting a prevalent and potentially fatal liver condition impacting millions globally. This landmark decision signifies a significant breakthrough for Madrigal Pharmaceuticals, distinguishing it from numerous larger competitors who have struggled or are still striving to penetrate this therapeutic area. In response to the FDA’s green light, Madrigal Pharmaceuticals witnessed a remarkable surge of over 20% in its shares during extended trading on Thursday.
Novo Nordisk and Eli Lilly are currently evaluating their flagship weight loss injections as potential therapies for the identical type of liver ailment, known as nonalcoholic steatohepatitis (NASH). Meanwhile, Madrigal’s medication, to be marketed under the name Rezdiffra, has gained specific approval for addressing NASH in patients exhibiting moderate-to-advanced liver scarring. The FDA stipulates that this treatment should be complemented with dietary adjustments and regular exercise.
NASH, an acronym for nonalcoholic steatohepatitis, presents a severe manifestation of liver disease marked by an accumulation of fat and inflammation within the liver. Left unchecked, it can progress to liver scarring, referred to as fibrosis, and ultimately result in liver failure or liver cancer. This condition frequently coexists with other health issues like high blood pressure, Type 2 diabetes, and obesity. The FDA cites an estimate indicating that approximately 6 million to 8 million individuals in the United States grapple with NASH, accompanied by moderate-to-advanced liver scarring.
Madrigal announced through a statement that the drug will hit the market in April. Additionally, the company unveiled an assistance program aimed at aiding individuals without insurance in obtaining access to Rezdiffra. However, Madrigal has yet to disclose the pricing for the treatment. Dr. Nikolay Nikolov, acting director of the FDA’s Office of Immunology and Inflammation, emphasized, “Previously, patients grappling with NASH and significant liver scarring lacked a medication capable of directly addressing their liver damage.”
Madrigal’s medication obtained a distinctive “accelerated approval” from the FDA, a designation designed to expedite the clearance process for drugs addressing unmet medical needs in severe conditions. This approval necessitates the drugmaker to conduct further studies to validate its clinical benefits. The mechanism of Madrigal’s medication involves activating a thyroid hormone receptor in the liver, facilitating the reduction of fat accumulation. Patients administer it orally on a daily basis.
In a recent late-stage study released last month, Rezdiffra demonstrated effectiveness in alleviating symptoms of NASH and enhancing liver scarring without exacerbating the condition. Importantly, the incidence of severe adverse events was similar between the group receiving the drug and the placebo group. The primary side effects associated with treatment included diarrhea, nausea, and vomiting. To steer clear of potentially stigmatizing language, certain specialists have begun referring to NASH as metabolic dysfunction-associated steatohepatitis, or MASH.
