CDER drafts drug development guidance on NASH with compensated cirrhosis
The Center for Drug Evaluation and Research (CDER) at the FDA issued draft recommendations for sponsors looking to develop drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis.
NASH is associated with a range of common diseases, including type 2 diabetes, hypertension and obesity, among others. “It is a growing public health concern and is anticipated to be the leading cause of liver transplantation within a decade,” the agency says. But “no standard treatment exists for NASH.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.