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

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

Boehringer’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

Click here to­ read full press release/ article | Ref: PRNewswire | Image:  Twitter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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