HRA Pharma Rare Diseases Registers the first Cushing’s Syndrome Treatment in Colombia

HRA Pharma Rare Diseases, an affiliate of HRA Pharma, a Perrigo Company, recently announced the registration of the first ever treatment for Cushing’s syndrome, Metopirone, in Colombia. Metopirone is a steroidogenesis inhibitor and works by suppressing the last step of cortisol synthesis in the adrenal gland, making it an effective medical treatment used to control serum cortisol levels in patients with endogenous Cushing’s syndrome.

Metopirone is indicated for the treatment of endogenous Cushing’s Syndrome for adult and paediatric patients and is already in use around the world, including in the EU, UK, Israel, Switzerland, and New Zealand. Efficacy and safety profiles of Metopirone treatment are supported by clinical evidence and the patients treated with Metopirone typically show improvement in the clinical features of Cushing’s Syndrome, such as high blood pressure, impaired glucose metabolism, psychiatric disturbances, and muscle weakness.

The registration of Metopirone reflects the dedication of HRA Pharma Rare Diseases to the people living with Cushing’s syndrome. Affecting between 0.7 and 2.4 per million population per year, Cushing’s Syndrome is a rare and severe condition caused by prolonged high levels of cortisol in the blood and is fatal without treatment.

The registration in Colombia comes as part of HRA Pharma’s decision to expand their global reach and strengthen their presence in key international markets, in order to ensure that no patient is left behind.

The registration was supported by the exclusive local partner, Valentech Pharma. The teams at HRA Pharma Rare Diseases worked alongside Valentech Pharma for 3 years on this project, producing all the necessary regulatory and medical resources for the registration to go ahead delivering a successful result despite being delayed due the Covid-19 pandemic.

Evelina Paberžė, COO of HRA Pharma Rare Diseases, said “Cushing’s Syndrome is a chronic condition that can be fatal if left untreated. As a company which is dedicated to improving the lives of those with rare diseases, we felt it was crucial to support the registration of a medicine that can help healthcare professionals in the treatment of Cushing’s Syndrome. We are confident that Metopirone will help improve the lives of many.”

Gabriel Muñoz Di Rocco, CEO of Valentech, added “This registration was the result of various teams working together to bring this vital medicine to the people who need it. Despite setbacks during the Covid-19 pandemic, and thanks to the tight collaboration between HRA and Valentech´s Regulatory teams, we have been able to secure the Marketing Authorization of Metopirone for the first time in Colombia, making it the only approved therapy for Cushing Syndrome in the country.”

Established in July 2019, HRA Pharma Rare Diseases was created as a result of HRA Pharma’s heritage in rare diseases and its close partnerships with the community. HRA Pharma Rare Diseases has a portfolio of medicines that address Cushing’s syndrome (CS) and Adrenal Cortical Carcinoma (ACC). Now well established in Europe, the company continues to grow, with future plans to expand its geographical reach worldwide. For more information, visit www.hra-pharma-rare-diseases.com.

Valentech Pharma was created 8 years ago by one of the cofounders of one of the pioneer pharma companies in bringing access to orphan disease patients in LATAM. Valentech Pharma has focused since its foundation exclusively on orphan drugs and orphan diseases, with products in endocrinology, neurology and hepatology. It currently has a portfolio of more than 10 orphan products, helping increase the access to unmet therapeutic needs. Cushing Syndrome being a difficult condition to diagnose and treat, Valentech Pharma is committed to help raise awareness for the patients of this disease. For more information, visit www.valentechforlife.com.