Boehringer Ingelheim’s Ofev (nintedanib) Receives FDA’s Advisory Committee Recommendation for Systemic Sclerosis Associated ILD

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 in FVC (-52.4ml vs -93.3ml)
• Ofev is a tyrosine kinase inhibitor indicated to treat IPF and has received FDA’s PR designation for SSc-ILD with its submission of sNDA to the US FDA and EMA in Q1’19

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