Posted by Michael Wonder on 07 Jun 2022
FDA approves drug for prevention of organ rejection in paediatric recipients of heart and liver transplants
7 June 2022 - The FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in paediatric recipients of allogenic heart and allogeneic liver transplants aged 3 months and older in combination with other immunosuppressants.
The use of CellCept in paediatric heart transplant and liver transplant patients is based on paediatric extrapolation of efficacy from adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients.
