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FDA Fast-Tracks New NASH Therapy
Find out about this new NASH therapy for liver health, and what it means that it’s being fast-tracked by the FDA.
On May 31, 2022, the U.S. Food and Drug Administration (FDA) reported that it has granted Pfizer Fast Track designation for a combination drug therapy that may help treat nonalcoholic steatohepatitis, also known as NASH. (1)
What is this new therapy and what does fast-tracking this drug mean?
Pfizer’s New Combination NASH Therapy
The new therapy that Pfizer is in the process of investigating is a combination of ervogastat and clesacostat.
- Ervogastat is a diacylglycerol O-acyltransferase 2 inhibitor that promotes the synthesis of triacylglycerol. It is also thought to aid in the treatment of liver steatosis. (2)
- Clesacostat is an acetyl-CoA carboxylase inhibitor, which is an enzyme that limits the rate of fatty acid metabolism. It has been implicated in the treatment of a variety of diseases, such as those that affect the liver. (3)
In a press release directly from Pfizer, the company indicated that the FDA granted Fast Track designation for this combination treatment. This was after reviewing results from both nonclinical and clinical studies that showed that this dual treatment not only reduces liver fat, but also appears to be well-tolerated by users and has a good safety profile. (4)
The reason this development is so important is, as the American Liver Foundation reports, at this moment in time, there are no FDA-approved medicines for treating NASH. (5)
Instead, this disease is often treated with recommendations to:
• lose weight
• exercise more
• lower cholesterol
• and reduce stress on the liver (such as by avoiding alcohol and taking other medications as instructed).
About FDA Fast Track Designation
So, what does it mean for this NASH therapy to receive Fast Track designation?
The FDA indicates that it can choose to fast track the review of a drug if that drug has been created to “treat serious conditions and fill an unmet medical need.” (6) The goal of this process is to help get new drugs to patients sooner when there are no existing treatment options that offer such a positive response.
While some worry that fast-tracking a drug means that isn’t adequately reviewed for safety or effectiveness, the FDA stresses that this isn’t the case. Receiving Fast Track designation simply means that the drug manufacturer has better access to the FDA through more frequent meetings and written communication. If certain criteria are met, the drug can also gain priority for being reviewed.
In the end, this allows the FDA to answer its questions about the drug’s safety and efficacy with greater speed. In turn, this also enables a therapeutic medicine to come to market sooner, where it can be used by patients to help treat their disease—in this case, treating the liver disease, NASH.
(1) FDA News. (2022, May 31). FDA Grants Fast-Track Label to Pfizer’s Combination Therapy for NASH. Retrieved June 3, 2022, from https://www.fdanews.com/articles/208025-fda-grants-fast-track-label-to-pfizers-combination-therapy-for-nash
(2) Pabst, B., Futatsugi, K., Qifang, L., Ahn, K. (2018, December 26). Mechanistic Characterization of Long Residence Time Inhibitors of Diacylglycerol Acyltransferase 2 (DGAT2). Biochemistry. doi:10.1021/acs.biochem.8b01096
(3) Wu, X., Huang, T. (2020, February 12). Recent Development in Acetyl-CoA Carboxylase Inhibitors and Their Potential as Novel Drugs. Future Medicinal Chemistry. Doi:10.4155/fmc-2019-0312
(4) Pfizer. (2022, May 26). Pfizer Granted FDA Fast Track Designation for Ervogastat/Clesacostat Combination for the Treatment of Non-Alcoholic Steatohepatitis. Retrieved June 03, 2022, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-granted-fda-fast-track-designation
(5) American Liver Foundation. (2021, August 10). What Are the Treatments for NAFLD and NASH? Retrieved June 03, 2022, from https://liverfoundation.org/for-patients/about-the-liver/diseases-of-the-liver/nonalcoholic-steatohepatitis-information-center/nash-treatment/#:~:text=The%20first%20line%20of%20treatment,important%20in%20managing%20your%20disease.
(6) U.S. Food and Drug Administration. (2018, January 04). Fast Track. Retrieved June 3, 2022, from https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
