Boehringer Ingelheim (Canada) has secured approval from Health Canada for its Ofev (nintedanib) to slow the rate of decline in patients suffering from systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Ofev is claimed to be the first and only treatment to slow the rate of decline in pulmonary function in patients with SSc-ILD.
ILD is considered to be a leading reason for death associated with SSc, representing 35% of all disease-related deaths. Around 40,000 people in Canada are estimated to be affected by systemic sclerosis.
The Canadian regulator has approved Ofev comes from results of SENSCIS, a double-blind, randomised and placebo-controlled, Phase III trial.
The study evaluated 576 patients across 32 countries, including Canada. The trial showed that Ofev slowed the loss of pulmonary function by 44% in patients with SSc-ILD compared to placebo, as measured by forced vital capacity (FVC) over 52 weeks.
Furthermore, the trial data indicated the safety and tolerability of Ofev in SSc-ILD patients. The FDA also approved nintedanib in SSc-ILD.
Ofev is already approved in over 70 countries to treat patients living with idiopathic pulmonary fibrosis (IPF).
Boehringer Ingelheim (Canada) medical and regulatory affairs vice president Dr Uli Brödl said: “With OFEV being the first therapy available in Canada to slow the rate of decline in pulmonary function for patients with SSc-ILD, it provides hope for these patients and their loved ones.
“This approval is supported by positive evidence from the Phase III SENSCIS study that showed that OFEV significantly slowed the progression of lung disease in this patient population.”
Boehringer Ingelheim reported net sales of around €17.5bn in 2018.
Its research and development expenditure was almost €3.2bn, corresponding to 18.1% of net sales. Boehringer established its Canadian headquarters in 1972 in Montreal, Quebec, now situated in Burlington, Ontario.