Madrigal Pharmaceuticals has commenced a rolling submission of a new drug application (NDA) seeking expedited approval from the US Food and Drug Administration (FDA) for its resmetirom to treat nonalcoholic steatohepatitis (NASH) with liver fibrosis.
The company has already submitted most of the application to the authority and intends to file the remainder in July 2023.
A priority review of the application will be sought by Madrigal.
In April 2023, resmetirom received a breakthrough therapy designation from the regulatory agency for this indication.
Madrigal was subsequently permitted to file individual portions of its NDA as they were finalised and awaiting completion of the full application.
Four Phase III trials of resmetirom are progressing to establish the product’s safety and efficacy in treating NASH.
Madrigal Pharmaceuticals research and development president and chief medical officer Becky Taub stated: “In the MAESTRO-NASH biopsy trial, resmetirom achieved both liver histological improvement endpoints proposed by FDA as reasonably likely to predict clinical benefit, and demonstrated a well-tolerated safety profile.
“We believe the positive results from MAESTRO-NASH support the potential of resmetirom to become a foundational therapy for NASH with liver fibrosis.
“The MAESTRO development programme will provide a robust data package to support the FDA’s review of the resmetirom NDA.”