USFDA approves Terlipressin for injection to treat Kidney function 

It is the first and only USFDA-approved product indicated to improve kidney function in adults

233
USFDA Approval
USFDA Approval

Last Updated on October 9, 2024 by The Health Master

The US Food and Drug Administration (USFDA) recently approved Mallinckrodt’s Terlivaz (terlipressin) for injection.

It is the first and only USFDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with a rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.

The USFDA approval was based, in part, on results from the phase-III Confirm trial, the largest-ever prospective study (n = 300) conducted to assess the safety and efficacy of Terlipressin in patients with HRS type 1 (HRS-1) in the US and Canada.

The Confirm trial met its primary endpoint of Verified HRS Reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival (p=0.012).

To achieve verified HRS reversal, patients had to have two consecutive serum creatinine (SCr) values of ≤1.5 mg/dL, at least two hours apart by day 14 or hospital discharge.

To be included in the primary efficacy endpoint analysis, patients had to be alive and without intervening renal replacement therapy (e.g., dialysis) at least 10 days after achieving Verified HRS Reversal.

Initial results were presented in a late-breaking session at The Liver Meeting 2019, the annual meeting of AASLD.

Results were also published in the New England Journal of Medicine in March of 2021. The Confirm trial was completed prior to the updated diagnostic criteria and terminology published in the 2021 AASLD guidance on the hepatorenal syndrome, the statement added.

The most commonly observed adverse reactions in at least four percent of patients treated with Terlivaz compared to placebo were:

  • Abdominal pain reported in 19.5 percent (n=39) of patients (vs. 6.1%; n=6),
  • Nausea reported in 16 per cent (n=32) of patients (vs. 10.1%; n=10),
  • Respiratory failure reported in 15.5 per cent (n=31) of patients (vs. 7.1%; n=7)
  • Diarrhoea reported in 13 per cent (n=26) of patients (vs. 7.1%; n=7)
  • Dyspnea reported in 12.5 per cent (n=25) of patients (vs. 5.1%; n=5).

USFDA gives tentative approval for Sugammadex Injection

USFDA gives approval for Lenalidomide capsules

USFDA gives final approval for Cariprazine capsules

USFDA gives approval for this cancer drug

USFDA approves Venlafaxine, Pregabalin extended release tablets

USFDA gives nod for SPEVIGO To treat Generalized Pustular Psoriasis Flares

PCI to amend Exit Examination Regulation for Diploma in Pharmacy

USFDA gives tentative approval for Sugammadex Injection

Drug alert: 45 out of 1330 samples declared as NSQ in August 2022

USFDA gives approval for Lenalidomide capsules

Panel recommends a separate legislation for Medical Devices

Govt adds 34 drugs in NLEM – National List of Essential Medicines

CDSCO classified Non-sterile, Non-powered, Hand-held Surgical Instruments

USFDA gives final approval for Cariprazine capsules

Role of IP in Pharmaceutical Industry

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news