This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2021
  • /
  • 8
  • /
  • FDA accepts sBLA for Orencia in severe acute graft...
News

FDA accepts sBLA for Orencia in severe acute graft versus host disease.

Read time: 1 mins
Published:24th Aug 2021
Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT).

The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 23, 2021.

The sBLA submitted to the FDA is based on results from the Phase II ABA2 trial and a registry trial based on real world evidence. The ABA2 trial assessed the impact of Orencia on the prevention of severe aGvHD, when added to a standard GvHD prophylactic regimen administered to patients with hematologic malignancies receiving a stem cell transplant from an unrelated, HLA-matched or mismatched donor.

A mismatch in HLA increases the risk of GvHD. Results from ABA2 showed that treatment with Orencia resulted in a significant reduction in severe aGvHD and associated morbidity without an increase in disease relapse. The findings of the real-world analysis were consistent with those of ABA2.

Condition: Graft-v-Host Disease (GvHD)
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Related news and insights