Johnson & Johnson has reached an agreement with the European Union regulator over the approval of its drugs Surgical, Share and Esmya to treat infections following organ transplantation.
“We are pleased to be able to approve the first new [uninfectious] combination drugs for transplant rejection in Europe in nearly five years,” said Patrick Wightman, J&J’s vice president of development & manufacturing in Europe. “Approval for new indications in transplant rejection marks a significant step forward as patients and transplant centers look to new, innovative therapies to help them in their search for longer and healthier life after transplant.”
As was reported previously by the Times, patients with autoimmune diseases, including Crohn’s disease, do not immunologically tolerate the transplant mixture and require cesarean delivery of transplant organs to avoid the onset of life-threatening organ rejection.
Surgical, which combines the immune suppressor drug Sutent with the anti-inflammatory drug prednisone, was first approved for use in the U.S. in 2012. However, it was not approved in Europe until September 2016, after a change in the European Medicines Agency’s review process.
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