Boehringer Ingelheim has announced that Canadians living with systemic sclerosis-associated ILD now have access to the pulmonary fibrosis medication OFEV (nintedanib) for slowing lung function decline.

Health Canada has approved OFEV® (Nintedanib) as a treatment for Canadians living with systemic sclerosis-associated interstitial lung disease (SSc-ILD) according to a November 27, 2019 press release by maker Boehringer Ingelheim.*

Systemic sclerosis (SSc), or scleroderma, is an autoimmune rheumatologic disease associated with excessive production and buildup of collagen. Collagen is the main structural protein of connective tissues in the skin and some internal organs, most often the lungs.

  • Lung damage caused by SSc is called fibrosis (scarring), or interstitial lung disease (ILD), affecting the tissue surrounding the air sacs (alveoli) of the lungs. ILD is a common complication of SSc. This disorder can also be accompanied by injuries to small arteries.
  • Accumulation of collagen thickens lung tissue and impedes oxygen transport into the bloodstream. It causes stiffness in the lungs which makes breathing difficult. ILD is the leading cause of death related to SSc.
  • A type of pulmonary fibrosis, roughly 40,000 Canadians are impacted by SSc-ILD, affecting mostly women aged 30-50.

The pharmaceutical company Boehringer Ingelheim (Canada) Ltd. announced that Health Canada has approved the oral prescription medication OFEV (nintedanib) as the first treatment indicated to slow the rate of decline in pulmonary function in patients with SSc-ILD. OFEV is an antifibrotic drug currently approved in Canada and more than 70 countries for the treatment of patients with pulmonary fibrosis (PF). The drug slows PF progression by reducing the annual rate of decline in lung function.

  • The approval is based on Phase III results of the SENSCIS® trial on 576 patients across 32 countries, including Canada.
  • Trial results showed that after one year, OFEV slowed loss of lung function in forced vital capacity by a significant 44%, or 41 mL, in patients with SSc-ILD versus control.
  • Results also showed OFEV to be safe and tolerable; common side effects included, for example, diarrhea, stomach upset, appetite and weight loss, tiredness, and pneumonia.

Dr. Sindhu Johnson, Associate Professor of Medicine at the University of Toronto and Director of the Toronto Scleroderma Program, said that he’s “excited” to be able to provide OFEV to patients with SSc-ILD because slowing by deterioration of the lungs “can help patients to live well despite their disease.”

Both the US Food and Drug Administration and Health Canada (Canada’s FDA equivalent) have now approved use of OFEV in SSc-ILD.

The press release, with more on the SENSCIS trial and Boehringer Ingelheim, can be found here.