European Commission approves nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD)

• Approval is based on the SENSCIS study which showed nintedanib slows the loss of pulmonary function in people living with systemic sclerosis-associated ILD (SSc-ILD)¹
• Following the FDA's approval in September 2019, nintedanib in SSc-ILD has so far been approved in 15 countries including Canada, Japan and Brazil
• Being the first and only approved treatment option available for people living with SSc-ILD, the approval constitutes a breakthrough in an area of high unmet need

Boehringer Ingelheim today announced that the European Commission has approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.² The approval comes after the Committee for Medicinal Products for Human Use had adopted a positive opinion for nintedanib in treatment of SSc-ILD on 27 February 2020.

Systemic sclerosis (SSc), also known as scleroderma, is a disfiguring, disabling and potentially fatal rare autoimmune disease.^3,4,5 It causes scarring (fibrosis) of various organs, including the lungs, heart, digestive tract and kidneys and can lead to life-threatening complications. When the lungs are affected, it can cause interstitial lung disease (ILD), known as SSc-ILD.^1,6 ILD is a leading cause of mortality, accounting for almost 35% of SSc-related deaths.⁷

"This is a real breakthrough in the treatment of people living with SSc-ILD," said Peter Fang, Senior Vice President and Head of Therapeutic Area Inflammation at Boehringer Ingelheim. "Once fibrosis of the lungs occurs it cannot be reversed. Nintedanib, being the first and only approved treatment for SSc-ILD, is serving a high unmet need making a real positive difference to those living with this life-changing condition. The approval is a further milestone in Boehringer Ingelheim's ongoing dedication for people living with pulmonary fibrosis."

"The European Commission's decision is very welcome news for the European scleroderma community," commented Sue Farrington, President of the Federation of European Scleroderma Associations (FESCA). "When scleroderma affects the lungs, there can be severe consequences. The availability of a therapy option brings great hope to those living with scleroderma and their loved ones."

The European Commission's approval is based on the results of the SENSCIS trial, a Phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of nintedanib in patients with SSc-ILD.¹ The primary endpoint was the annual rate of decline in forced vital capacity (FVC) assessed over a 52-week period. Results showed nintedanib slowed the loss of pulmonary function by 44% (41mL/year) relative to placebo, as measured in FVC over 52 weeks.¹ Furthermore, results showed that nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF).¹

Regulatory approvals for the treatment of patients living with SSc-ILD have also been granted in several countries including Canada, Japan and Brazil. Nintedanib is approved in over 75 countries for the treatment of IPF, and it is the first approved treatment for SSc-ILD.⁸

~ENDS~

Please click on the link for 'Notes to Editors' and 'References': http://www.boehringer-ingelheim.com/press-release/europeancommissionapprovesnintedanibssc-ild

View source version on businesswire.com: https://www.businesswire.com/news/home/20200421005328/en/

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