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Orphan Drug Designation Granted to Nintedanib for Treatment of Systemic Sclerosis
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Boehringer Ingelheim announced nintedanib has been granted orphan drug designation by the European Commission and the FDA for the treatment of systemic sclerosis, including associated interstitial lung disease.
According to a company press release, nintedanib is being evaluated in the Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS) study, which was designed to measure the efficacy and safety of nintedanib 150 mg twice daily for 52 weeks up to a maximum of 100 weeks among patients with systemic sclerosis with associated interstitial lung disease (SSc-ILD).
“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 systemic sclerosis, also known as scleroderma,” William Mezzanotte, MD, the therapeutic area head of respiratory medicine at Boehringer Ingelheim, said in the release. “The need for treatment options for people with SSc-ILD is significant, and the SENSCIS trial is an important first step in exploring the benefit of nintedanib in addressing the complications of systemic sclerosis. The success of nintedanib in treating [idiopathic pulmonary fibrosis] 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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