Madrigal Pharmaceuticals, a biopharmaceutical company located near Philadelphia, is focused on treating Non-Alcoholic Steatohepatitis (NASH) and developing new drugs for its management. In a major win for patients, the company achieved a significant milestone in 2024: FDA approval for its new drug to treat adults with NASH and fibrosis, but without cirrhosis. We’re diving deeper into the company and its groundbreaking product. Read more at philadelphia.name.
Madrigal Pharmaceuticals Leadership
Madrigal Pharmaceuticals boasts a strong and dynamic leadership team. The company’s founder, director, chief medical officer, and head of research and development is Dr. Rebecca Taub. Dr. Taub has over 20 years of experience in drug development, with a career spanning several prominent companies:
- VIA Pharmaceuticals (Senior Vice President of Research and Development)
- Hoffmann-La Roche (Vice President of Metabolic Disease Research)
- Bristol Myers Squibb
- DuPont Pharmaceuticals
In addition to her industry roles, Dr. Taub also taught genetics and medicine at the University of Pennsylvania.
Bill Sibold serves as the company’s Chief Executive Officer. With over 30 years in the biopharmaceutical field, he previously held the position of Executive Vice President at Sanofi, where he led the company’s North American operations. In that role, he oversaw more than 10,000 employees and was a member of the executive committee. Mr. Sibold’s extensive background also includes leadership roles at well-known companies like Avanir Pharmaceuticals, Lycera Corp., and Biogen.
Together, this leadership duo assembled a team of leading specialists determined to create a treatment for Non-Alcoholic Steatohepatitis (NASH), a highly competitive area in drug development. Despite the ambitious nature of their plans, the Philadelphia-based company successfully brought them to fruition.
A Drug to Treat NASH
In 2024, Madrigal Pharmaceuticals made history as the first pharmaceutical company to have a NASH treatment approved by the U.S. Food and Drug Administration (FDA). This severe liver disease, also known as steatohepatitis associated with metabolic dysfunction, often goes undiagnosed, and many patients lacked adequate treatment options until now.
Madrigal Pharmaceuticals submitted their groundbreaking drug to the FDA in the fall of 2023, and in March 2024, it received approval. The drug will now be prescribed alongside diet and exercise for the treatment of NASH with liver fibrosis. The international non-proprietary name for this new medication is resmetirom, and it will be marketed in the U.S. under the brand name Rezdiffra.
The new drug is an oral beta-selective agonist of thyroid hormone receptor-beta (THR-β). It offers multiple therapeutic actions on the liver and helps normalize fat metabolism in the human body. According to clinical trial data, it can be prescribed without the need for a liver biopsy, which is expected to increase its usage and positively impact the treatment of NASH patients.
The relatively swift FDA approval of the new drug was largely due to the compelling data provided by the company from two stages of its Phase 3 clinical trials. The results showed that the majority of patients receiving resmetirom experienced positive changes in histological parameters compared to the placebo group.
The manufacturer’s price for a year’s course of the drug is $47,400. Projected annual sales are estimated to be between $2 and $3 billion. Some experts believe that under these circumstances, Madrigal Pharmaceuticals might be acquired by a larger pharmaceutical corporation, but the company’s leadership has not commented on such speculation and continues its operations in its established direction.
It’s important to note that before Madrigal Pharmaceuticals’ breakthrough, all previous attempts to create and bring such a drug to the pharmaceutical market had failed. Thus, the Philadelphia-based company managed to surpass competitors like Albireo, Intercept, Genfit, Gilead, Cirius, CymaBay, NGM Biopharma, and many others.
What is NASH?
NASH is a leading cause of liver-related mortality. Patients suffering from this disease have an increased risk of developing and dying from cardiovascular diseases, such as strokes and heart attacks. Typically, they also have co-occurring conditions like high blood pressure, obesity, and type 2 diabetes.
The disease is characterized by liver tissue fibrosis, which impairs the liver’s ability to detoxify the body. In the U.S., NASH is one of the primary indications for liver transplantation, but this treatment pathway is incredibly expensive and arduous. This is precisely why the development of specific medications has become such a critical task for the pharmaceutical industry.
Madrigal Pharmaceuticals successfully created a selective thyroid hormone receptor agonist and demonstrated its effectiveness in clinical trials. Given the compelling information provided, the FDA quickly approved the new oral drug. Now, patients finally have access to effective and timely treatment.