Nintedanib Gains Fast Track Designation for Systemic Sclerosis


Nintedanib (Ofev) is currently indicated to slow disease progression among patients with idiopathic pulmonary fibrosis.

Boehringer Ingelheim recently announced that the FDA granted fast track designation to nintedanib (Ofev) for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD), according to a company press release. Systemic sclerosis is a rare disease also known as scleroderma.

“This fast track designation is an encouraging step in our ongoing research and commitment to advancing care of those with systemic sclerosis with interstitial lung disease,” said Christopher Corsico, MD, chief medical officer, Boehringer Ingelheim. “It is critical that we address the significant unmet medical need of those living with this disease and we are looking forward to working with the FDA to advance the development of this potential therapy.”

The investigational new drug application for nintedanib was based on anticipated safety and efficacy data from the phase 3 SENSCIS clinical trial.

Related Coverage: Orphan Designation Granted to Systemic Sclerosis Drug

The trial evaluated the safety and efficacy of nintedanib 150-mg twice daily from 52 weeks to 100 weeks in patients with SSc-ILD. Included in the trial were more than 520 patients from 32 countries.

The primary endpoint was annual rate of decline in forced vital capacity and secondary endpoints included change from baseline in the modified Rodnan Skin Score and the change from baseline in the Saint George´s Respiratory Questionnaire total score, according to the release.

Systemic sclerosis, which typically affects women aged 25 to 55 years, is characterized by the thickening and scarring of the connective tissue of organs. A majority of patients also develop scarring or interstitial lung disease, which is the leading cause of death among this population, according to the release.

Nintedanib is indicated to treat idiopathic pulmonary fibrosis (IPF) and has been shown to reduce disease progression measured by annual rate of lung function decline. Due to the similarities in fibrosis between SSc-ILD and IPF, Boehringer is exploring the efficacy of nintedanib among patients with SSc-ILD, according to the release.

“There have been no FDA-approved treatment options for scleroderma with lung involvement and very few drugs assessed in clinical trials for a devastating reality for people living with the disease,” said Robert Riggs, chief executive officer, Scleroderma Foundation.

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