FDA Grants Priority Review for Madrigal Pharma's Non-Alcoholic Steatohepatitis (NASH) Treatment

Jul 22 2025

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FDA Grants Priority Review for Madrigal Pharma’s Non-Alcoholic Steatohepatitis (NASH) Treatment

Madrigal Pharmaceuticals, a leading clinical-stage biopharmaceutical company dedicated to advancing innovative treatments for nonalcoholic steatohepatitis (NASH), has exciting news to share. The U.S. Food and Drug Administration (FDA) has officially accepted the company’s New Drug Application (NDA) for resmetirom, a potential breakthrough therapy for adult NASH patients with liver fibrosis.

Publish Date: 13-09-2023 Source: Madrigal Pharmaceuticals

Endometrial carcinoma (EC) is the most common gynecologic malignancy that almost every gynecologist will encounter. The most common symptoms are abnormal uterine bleeding and vaginal discharge. Patients with advanced disease may have symptoms similar to those seen with advanced ovarian cancer, such as abdominal or pelvic pain, abdominal distension, early satiety, or a change in bowel or bladder function. Women with recurrent or advanced endometrial cancer constitute a heterogeneous group of patients. Most patients with endometrial cancer are diagnosed at an early stage (Stage I or II) and have a more favorable prognosis compared with patients diagnosed with advanced (Stage III or IV) disease (5-year survival rates of >74% vs. ≤15%, respectively). Prognosis is also poor for patients with distant recurrent disease (median survival of <5 years).

  • The prevalence of endometrial cancer in the United States is 25.7/100,000 women per year.

However, the current Non-Alcoholic Steatohepatitis (NASH) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Semaglutide, Obeticholic acid, IVA337, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Non-Alcoholic Steatohepatitis treatment. The key companies in the advanced development stage are Novo Nordisk A/S, Intercept Pharmaceuticals, Inventiva Pharma, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Non-Alcoholic Steatohepatitis (NASH) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.

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