Health Canada has approved Ofev (nintedanib) to treat patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).
Systemic sclerosis affects up to 40,000 Canadians and interstitial lung disease is the leading cause of death among people with systemic sclerosis or scleroderma. The condition mostly affects women between the ages of 30 and 50 years.
Nintedanib is a tyrosine kinase inhibitor that is also approved to treat idiopathic pulmonary fibrosis (IPF). Both IPF and SSc-ILD are conditions known as pulmonary fibrosis in which lungs become scarred and stiff. Various tyrosine kinases that nintedanib targets are involved in the pathophysiology of pulmonary fibrosis.
The approval was largely based on a Phase III double-blind randomized, placebo-controlled trial, involving 576 patients with SSc-ILD. The primary endpoint was the annual rate of decline in FVC and the study observed that nintedanib slowed the loss of pulmonary function by 44% (41 mL/year) compared to placebo. This study was published in the New England Journal of Medicine earlier this year.
The most common adverse events found with nintedanib were diarrhea, nausea, vomiting, abdominal pain, liver enzyme elevation, weight decreased, fatigue, decreased appetite, pneumonia, musculoskeletal pain, dizziness and hypertension.
In a news release, Martin Kolb, MD, Director of the Division of Respirology at McMaster University said, “medical advancements, like the approval of Ofev (nintedanib), are a rare thing when it comes to treating conditions like systemic sclerosis,” adding, “we now have the unprecedented opportunity to care for our patients in a different way that offers hope by slowing down the progression of this disease.”
Sindhu Johnson, Director of the Toronto Scleroderma Program and Associate Professor of Medicine at the University of Toronto added, “I am excited to now be able to offer patients Ofev (nintedanib), which, by slowing the deterioration (or worsening) of the lungs, can help patients to continue to live well despite their disease.”