Janssen bags USFDA nod for IMBRUVICA for chronic graft-versus-host disease treatment
Chronic graft-versus-host disease is a life-threatening complication that can occur after a stem cell or bone marrow transplant when newly transplanted donor cells attack the transplant recipient's body.;
New Delhi: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the U.S. Food and Drug Administration (USFDA) has approved IMBRUVICA (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft-versus-host disease (cGVHD) after the failure of one or more lines of systemic therapy.
"This milestone marks the first pediatric indication for IMBRUVICA and the introduction of a new oral suspension formulation for patients ages one to less than 12. IMBRUVICA is now the first FDA-approved therapy for these younger patients who previously had no approved treatment options for this life-threatening disease," claims the company.
Chronic graft-versus-host disease is a life-threatening complication that can occur after a stem cell or bone marrow transplant when newly transplanted donor cells attack the transplant recipient's body. Symptoms may include skin rash, mouth sores, dry eyes, liver inflammation, development of scar tissue in the skin and joints, and damage to the lungs. Among children who undergo allogeneic transplants, 52-65 percent will develop cGVHD.
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