8 January 2018 - The Center for Biologics Evaluation and Research worked diligently during Fiscal Year 2017 to fulfil its core mission: ensuring that safe and effective biologic products and related devices are available to the public.

We are particularly proud to have approved several therapeutic “firsts” that represent significant achievements in fulfilling our mission: Kymriah, the first gene therapy in the US, which is approved for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia that is refractory or in second or later relapse; MACI, the first FDA-approved product for repairing knee cartilage defects in adults that is grown from cells on scaffolds using healthy cartilage tissue from the patient’s own knee; Odactra, the first allergenic extract to be administered under the tongue for the treatment of house dust mite-induced nasal inflammation; and Haegarda, the first subcutaneous preventive treatment option for hereditary angioedema (HAE), which enables easier at-home self-injection by the patient or caregiver, to prevent HAE attacks in adolescent and adult patients.

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