Mallinckrodt plc announced the resubmission of the Company's New Drug Application (NDA) to the FDA for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition for which there is currently no FDA-approved treatment. Terlipressin is an investigational agent being evaluated for the treatment of HRS in the U.S., and its safety and effectiveness have not yet been established by the FDA.
The resubmission follows ongoing discussions with the FDA resulting from a Complete Response Letter (CRL) received on February 18, 2022. In the two weeks prior to the PDUFA date of February 18, 2022, it became necessary to identify a new third-party packaging and labeling facility. While Mallinckrodt identified a new facility, an FDA inspection of the facility could not be completed by the February PDUFA date, resulting in the receipt of the CRL. For the NDA to be approved, the new facility must be inspection ready at the time of filing. This was the only outstanding issue noted in the CRL, as there were no safety or efficacy issues cited.
Terlipressin is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date. It has been approved outside the U.S. for more than 30 years, is available on five continents, and is considered the standard of care for its two indications in the countries where it is approved.
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