Tags : nintedanib

Regulatory

Boehringer Ingelheim’s Ofev (nintedanib) Receives Health Canada’s Approval as the

Shots: Health Canada approved Ofev (nintedanib) as the first and only treatment, indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease The approval is based P-III SENSCIS study assessing Ofev vs PBO in 576 patients with SSc-ILD across 32 countries including Canada, resulted in slowing loss […]Read More

Regulatory

Boehringer Ingelheim’s Ofev (nintedanib) Receives FDA’s Advisory Committee Recommendation for

Shots: The FDA’s Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) The FDA’s recommendation is based on P-III SENSCIS study assessing Ofev vs PBO in 576 patients SSc-ILD resulted in a reduction in loss of pulmonary function by 44% and @52wks. rate of decline […]Read More