2023-06-30 11:52:13 ET
Madrigal Pharmaceuticals ( NASDAQ: MDGL ) has initiated a rolling submission of its New Drug Application to US regulators for its drug candidate resmetirom for the treatment of nonalcoholic steatohepatitis, or NASH, with liver fibrosis.
The biotech company said it has submitted most of the application, with the remainder slated for submission in July .
Madrigal is seeking accelerated approval for the drug and plans to request that the application be awarded Priority Review status, meaning that the US Food and Drug Administration would decide on whether to approve the product within six months of receipt of the application rather than the usual ten-month period.
Accelerated approval allows for a drug for a serious condition for which there are few treatments available to be approved based on a study's surrogate endpoint.
The FDA granted breakthrough status to resmetriom for NASH with liver fibrosis in April, which allows for the NDA to be submitted in sections.
More on Madrigal:
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Drug pricing watchdog raises alarm over upcoming liver disease meds
Madrigal rises on FDA breakthrough therapy tag for liver disease drug resmetirom
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Madrigal starts rolling submission of US market application for NASH drug