ITB-Med receives FDA Orphan Drug Designation for Siplizumab in the United States

  • On February 19, 2018
  • Regulatory press release

Regulatory press release: ITB-Med´s application for Orphan Drug Designation (ODD) for Siplizumab was approved on February 15, 2018 in the United States.

The US Food and Drug Administration (FDA) granted ITB-Med´s ODD, pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), for prevention of solid organ transplant rejection.

“We are very pleased that FDA has granted Siplizumab Orphan Drug status in the United States. Together with the previously approved Orphan Drug Designation in the EU, ITB-Med can now access development and commercial incentives in the majority of the transplant market worldwide, including 7 years and 10 years market exclusivity, respectively, after market approval. As a key treatment component, Siplizumab’s ability to allow safe long-term complete immunosuppression withdrawal in organ transplant patients has proven to be of significant clinical benefit. We are encouraged by FDA´s decision and are continuing our work toward registration”, says Erik Berglund, CEO at ITB-Med AB.