The National Health Surveillance Agency (Anvisa) approved on Monday (16) an unprecedented treatment for adults with pulmonary arterial hypertension a rare and progressive disease characterized by high pressure in the lung arteries. The medicine, called Winrevair (sotatercept), was developed by pharmaceutical company MSD.
The new treatment aims to increase patients’ exercise and locomotion capacity, improve Functional Class [índice de gravidade da doença] of the World Health Organization (WHO) for the disease, and reduce the risk of complications.
The drug is the first activin signaling inhibitor approved by the Food and Drug Administration (FDA), the United States regulatory body for pulmonary arterial hypertension, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate the proliferation of vascular cells underlying the disease. The drug has already received Breakthrough Therapy Designation from the FDA.
Pulmonary arterial hypertension often leads to shortness of breath, even with light exercise, as well as dizziness and fatigue. The disease can have different causes, including heart failure, chronic diseases that form blood clots, and lung disorders or low blood oxygen levels, according to the MSD Manual.
“Pulmonary arterial hypertension is a debilitating and progressive disease, with a high rate of mortality and morbidity, often disabling the patient from carrying out simple daily tasks, such as climbing a staircase”, comments Márcia Datz Abadi, medical director of MSD Brasil, in press release.
“The approval of WINREVAIR (sotatercept) in Brazil is an important milestone for the country’s healthcare sector, and reinforces our commitment to developing innovative treatments that can improve the quality of life of people suffering from rare diseases”, he adds.
Treatment approval was based on the results of the Phase 3 clinical study “STELLAR”which compared Winrevair to placebo, both in combination with background therapies in adult patients with pulmonary arterial hypertension.
According to the study, adding the new drug to basic therapy increased the distance covered by patients by 41 meters when performing the Six-Minute Walk Test, used to evaluate lung and cardiovascular diseases. Furthermore, the treatment reduced the risk of death and clinical worsening due to the disease by 84%, when compared to basic therapy alone.
In November, MSD globally announced positive results from another clinical study related to Winrevair, designed to evaluate whether adding the drug to the mainstay of pulmonary arterial hypertension could reduce the risk of death, lung transplantation or hospitalizations for patients living with the disease. at an advanced stage. The work presented positive results and became the first study related to the disease to have an early conclusion from the FDA.
The medicine is administered once every three weeks by subcutaneous injection and can be administered by patients and caregivers, after training and monitoring by a healthcare professional.
This content was originally published in Pulmonary arterial hypertension: unprecedented treatment is approved by Anvisa on the CNN Brasil website.
Source: CNN Brasil
I am an experienced journalist and writer with a career in the news industry. My focus is on covering Top News stories for World Stock Market, where I provide comprehensive analysis and commentary on markets around the world. I have expertise in writing both long-form articles and shorter pieces that deliver timely, relevant updates to readers.
