The US FDA issued a Complete Response Letter (CRL) regarding Mallinckrodt's New Drug Application for the investigational agent terlipressin, designed to treat adults with hepatorenal syndrome type 1 (HRS-1).
HRS-1 is a life-threatening syndrome involving acute kidney failure in people with cirrhosis. There is no approved treatment in the U.S. at present. Mallinckrodt's Terlipressin, which got the green light from the FDA advisory committee back in July, is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1
According to the FDA's CRL, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for patients with HRS-1.
"We are surprised by and disagree with the FDA's decision and remain committed to pursuing all available options as we continue working with the FDA toward approval of terlipressin in order to help address this difficult and life-threatening syndrome." said the company in a press release.
Read the press release
