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Orphan drug designation granted to Boehringer Ingelheim’s systemic sclerosis drug

13 September 2016  •  Author: Niamh Louise Marriott, Digital Content Producer

The European Commission (EC) and US Food and Drug Administration (FDA) have both granted orphan drug designation to Boehringer Ingelheim’s nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD).


Senscis is specifically evaluating nintedanib to understand the disease process and potential benefit of the compound to treat SSc-ILD.

Systemic sclerosis, commonly referred to as “scleroderma,” is a disfiguring, disabling and potentially fatal rare disease that can cause scarring of the skin, lungs (SSc-ILD) and other organs. Worldwide an estimated 1 in 3000 people have systemic sclerosis3 (scleroderma) and up to 90% may develop some degree of lung scarring. SSc-ILD accounts for 35 percent of all disease-related deaths.

“Scleroderma and associated interstitial lung disease have a devastating impact on the patient community, and we welcome this important news that a potential new treatment has received orphan drug designation. It’s a crucial step forward in helping to address an unmet need and represents important progress for patients with this rare disease,” said Joep Welling, Federation of European Scleroderma Associations (FESCA aisbl).

“The Orphan Drug Designation granted by both the European Commission and FDA for nintedanib is an important milestone in the development of much needed therapies for the various complications of scleroderma” said Dr William Mezzanotte, Therapeutic Area Head, Respiratory Medicine at Boehringer Ingelheim.

“The need for treatment options for people with SSc-ILD is significant, and the SENSCISTM trial is an important first step in exploring the benefit of nintedanib in addressing the complications of scleroderma.

The success of nintedanib in treating IPF, in both clinical trials and the clinical world, along with similarities of IPF to other fibrotic lung diseases, including SSc-ILD, gives us great hope that this important medicine can help patients with SSc-ILD.”

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