FDAnews
www.fdanews.com/articles/195109-health-canada-approves-boehringer-ingelheims-ofev-for-systemic-sclerosis
HealthCanada_Logo.gif

Health Canada Approves Boehringer Ingelheim’s Ofev for Systemic Sclerosis

December 11, 2019

Boehringer Ingelheim grabbed Health Canada’s approval for Ofev (nintedanib) to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease.

The approval was based on the results of a phase 3 double-blind randomized, placebo-controlled trial involving 576 patients across 32 countries. The study showed that Ofev slowed the loss of pulmonary function by 44 percent in patients with the disease relative to placebo.

Ofev is currently approved in more than 70 countries to treat patients with idiopathic pulmonary fibrosis.

View today's stories