Horizon Pharma Sees Mid-2019 BLA For Tepro After Solid Phase III TED Data
Horizon Pharma is on track to file its top pipeline asset for regulatory approval this year after its Phase III confirmatory trial evaluating teprotumumab for the treatment of active thyroid eye disease met primary and secondary endpoints.
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Despite COVID-19, Horizon Therapeutics has pulled off a spectacularly successful launch of its thyroid eye disease therapy, Tepezza, thanks to pre-commercial activities that led to a high level of initial patient and prescriber awareness, and market access teams securing a decent reimbursement rate.
FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.
With US FDA action on teprotumumab anticipated in March, Horizon has assembled a 100-person commercial team to begin educating physicians and payers on the rare autoimmune condition thyroid eye disease (TED).