FDA grants orphan drug designation to Nintedanib for Systemic Sclerosis

Release Date: 03-Oct-2016

Boehringer Ingelheim’s nintedanib has been approved as orphan drug for the treatment of systemic sclerosis (SSc), also called scleroderma. FDA has taken an inevitable step forward in prevention and cure of Scleroderma, including associated interstitial lung disease.
SSc is a rare disease causing scratches over skin, lungs and other organs, resulting into disability. Almost 2 million of people are suffering from SSC, out of which, 90% patients have been diagnosed with scarring in lungs. SSC holds a record of 35% of deaths caused by all the disease-related deaths in the world.
Nintedanib’s safety and efficacy in treating SSc is being evaluated in SENSCIS, the largest trial to date in this disease area. The randomized, double-blind, placebo-controlled study is designed to measure the nintedanib 150 mg which is taken twice daily for over 52 weeks up to 100 weeks in patients with SSc-ILD. The primary endpoint is the annual rate of decline in forced vital capacity, while secondary endpoints include the absolute change from baseline in the modified Rodnan Skin Score.


For Orphan Drug Clinical Insight Reports Contact: neeraj@kuickresearch.com

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