The Ministry of Health and Welfare Wednesday provided an additional coverage for GlaxoSmithKline’s Volibris (ambrisentan) to treat people who have congenital heart disease-related pulmonary arterial hypertension, GlaxoSmithKline Korea said.
“There have been no insurance benefits for [this indication], making it difficult for both healthcare workers and patients to treat the disease,” said Hong Yoo-seok, CEO of GSK Korea. “We look forward to improving our patients’ health with active prescriptions for the drug.”
Pulmonary arterial hypertension (PAH) is characterized by a severe constriction of the lung’s blood vessels that makes physical activity difficult. A congenital heart defect (CHD) is the most common type of congenital disability characterized by a problem with the structure of the heart.
CHD-related PAH is a rare disease, with GSK Korea estimating around 2,000 Korean patients suffering from PAH alone, and around 25 percent of PAH patients with the congenital disability.
Volibris is an endothelin receptor antagonist (ERA) used commonly to treat adult PAH patients who have a slight or significant limitation in physical activity (referred to as Class II and Class III, respectively, by the World Health Organization).
The drug significantly improved exercise capacity in class II and III patients compared with placebos in two double-blind, multicenter trials (ARIES-1 and ARIES-2), GSK Korea said.
“Results from a study of CHD-related PAH patients also confirmed the efficacy of the drug in improving exercise capacity, delaying clinical deterioration, and proving low hepatoxicity in these patients,” Hong said.
Ambrisentan does have a high risk of causing liver damage and pregnancy complications such as congenital disabilities, the company noted, saying it is essential to check for serum aminotransferase levels before starting treatment.
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