Regulatory Review of New TED Drug
TFC is supporting the Canadian regulatory review of the teprotumumab (Tepezza) drug for treating Thyroid Eye Disease produced by Amgen biopharmaceuticals.
This review is part of the standard Health Technology Assessment process established by Canada’s Drug Agency (CDA) for the approval of new drugs. We were approached by Amgen this summer to assist them with this effort and we are working with a third party, Eversana, to develop and compile a survey and CDA submission for approval of their teprotumumab (Tepezza) product in Canada. TFC will review all the material and make the official submission of the survey results to CDA on Nov. 1st.
Read the detailed article about this review in the fall issue of our Thyrobulletin newsletter.