Horizon Pharma applies to FDA for approval of teprotumumab for active thyroid eye disease

HorizonPharmaceuticals(http://,(http:// recently announcedthat it had filed a biologics licensing application (BLA) with the u.SFood andDrug(http://Administration (
FDA(http://for approval of teprotumumab for treatment for active thyroid eye disease (TED)The company has requested a priority review of the BLAIn this ue FDA has granted teprotumumab therapeutic active TED breakthrough drug qualification, orphan drug qualification, fast-track qualificationAbout teprotumabteprotumumab is an all-human IgG1 monoantigen that targets insulin-like growth factor-1 receptors (IGF-1R), developed for the treatment of moderate to severe thyroid eye disease (TED), which is usually associated with Grave's disease (Grave's disease, hyperthyroidism) related research
submitted by teprotumumab BLA, based on positive data from confirmed Phase III clinical studies of OPTIC 　　Top-line results, published in March this year, showed significant improvements in eye pronouns or bulge swelling in patients in the teprotumumab treatment group compared to the placebo group: 82.9% of patients in the teprotumumab treatment group reached the primary endpoint of eye protrusion or bulging reduction of 2mm or more, compared with 9.5% in the placebo group, with statistically significant differences in data (p 0.001) Prostrusion (proptosis) is the main cause of the disease in Patients with TED 　　The study also reached all secondary endpoints security
the safety profile of teprotumumab is consistent with the drug's treatment tED Phase II study