CHMP adoptes positive opinion, for Tepezza (teprotumumab) for treatment of adults with moderate to severe thyroid eye disease – Amgen

The EMA has recommended granting a marketing authorisation in the European Union (EU) for Tepezza (teprotumumab), for the treatment of adults with moderate to severe thyroid eye disease. The CHMP’s opinion is based on data from three randomised, placebo-controlled trials in a total of 225 patients with active TED, and one trial in 62 patients with chronic TED. After 24 weeks, patients treated with Tepezza experienced a significant reduction (-2 to -2.3 mm) in protrusion of the eyeball from the eye socket (proptosis) and in the Clinical Activity Score (CAS), a standard tool to evaluate inflammatory signs and symptoms of TED, compared to patients treated with placebo. The reduction in proptosis was smaller (-1.5mm) in patients with chronic TED.

The opinion adopted by the CHMP is an intermediate step on Tepezza’spath to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.