The drug Terlipressin (Mallinckrodt, Staines-upon-Thames, UK) made it out of an FDA advisory committee with an 8-7 vote for approval. At the recent Cardiovascular and Renal Drugs Advisory Committee meeting, participants pointed out benefits, but also some weaknesses of the drug, which was evaluated for its use in the treatment of hepatorenal syndrome type 1 (HRS-1). This kidney condition can develop in patients with acute or chronic liver disease with advanced liver failure and portal hypertension, and patients have poor survival rates.
Among other data, the FDA panel looked at data from a phase 3 trial of 300 patients, which showed a risk of respiratory failure that affected 10% of patients taking Terlipressin, but only 3% of those on placebo. Deaths from sepsis and septic shock were also more prevalent in the Terlipressin arm when compared with the placebo arm.
Regarding the drug’s risks, Daniel Bonner, the advisory committee’s patient representative, said the choice to take such risks should be up to the patients, who should be able to weigh a medicine’s complications with the possibility of having more time to live.
