FDA approves first drug to improve kidney function in HRS patients

The US Food and Drug Administration (FDA) today announced it has approved Terlivaz (terlipressin) injection to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. Terlivaz is the first FDA-approved medication for this condition.

The drug was developed by Ireland-headquartered Mallinckrodt (NYSE: MNK), whose shares were up 10% at $14.40 in mid-morning trading. Mallinckrodt, which filed for US approval back in March 2020, says that Terlivaz is expected to be available in the USA in the coming weeks.

Terlipressin, marketed under the Lucassin and Variquel brand names for the management of low blood pressure, is already approved for use in Europe, Latin America, Asia and Australia.