Horizon Therapeutics announced the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA as the first and only medicine approved in Brazil for treatment of thyroid eye disease.
Horizon Therapeutics recently announced the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) has approved TEPEZZA for the treatment of thyroid eye disease (TED).
This makes TEPEZZA the first and only medicine approved for treatment of TED in Brazil, according to a press release from the company.1
Vikram Karnani, executive vice president and president, global commercial operations and medical affairs, Horizon discussed the impact the medicine will have in Brazil in the press release.
“Brazil is now the first country outside of the United States to approve TEPEZZA and this further reinforces our commitment to the global rare disease community,” Karnani said.
“The TED community in Brazil now has an approved medicine that has been proven in clinical studies and over three years of real-world use in the United States to treat the debilitating symptoms of TED, such as eye bulging, double vision and pain.”
According to the company, the approval was based on the OPTIC Phase 3 trial that helped serve as the basis for the FDA approval back in January 2020.
This approval comes just days after the announcement of positive topline data from a Phase 3 clinical trial of TEPEZZA in Japan.
Yuji Hiromatsu, MD, professor emeritus, Kurume University Medical Center and co-coordinating trial investigator, discussed those results in a separate press release from the company.2
“The positive topline results from this trial are important because there are no approved medicines in Japan for Thyroid Eye Disease, resulting in a significant unmet need for patients who are struggling with the physical symptoms of the disease as well as the emotional and social burden that is associated with it,” Hiromatsu said.
“Currently, the only treatment options in Japan are steroids and multiple invasive surgeries. TEPEZZA would offer patients a non-surgical option that not only treats the symptoms, such as proptosis and diplopia, but targets the underlying mechanism of the disease.”
The topline data from the trial showed that at week 24, “89% of patients treated with TEPEZZA had a clinically meaningful improvement in proptosis (≥2 mm) compared with placebo (11%) (p<0.0001).”