Boeringer Ingelheim announced this morning that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD).
The designation is based on the Investigational New Drug (IND) application submitted by the company for the drug, as well as the anticipated safety and efficacy data from SENSCIS (Safety and Efficacy of Nintedanib in Systemic SClerosIS) Phase 3 trial. The pivotal study is double-blind, randomized, placebo-controlled, and fully enrolled, including more than 520 patients from 32 countries.
To date, no treatment options for the indication have been approved by the FDA, and very few drugs even assessed in clinical trials. Nintedanib, however, has been shown to slow disease progression as measured by annual rate of decline in lung function.
“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, M.D., Chief Medical Officer, Boehringer Ingelheim in a press release
. “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.”
Systemic sclerosis, commonly referred to as scleroderma, is characterized by the thickening and scarring of connective tissue of multiple organs in the body. It typically affects women between ages 25 and 55, and most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is the leading cause of death among people in the patient population.
The SENSCIS study will evaluate nintedanib at 150 mg twice daily over 52 weeks up to a maximum of 100 weeks in people with SSc-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of lung disease progression. Key secondary endpoints include the absolute change from baseline in the modified Rodnan Skin Score (mRSS), which is an evaluation of the thickness of people’s skin, and the absolute change from baseline in the Saint George’s Respiratory Questionnaire (SGRQ) total score, which measures the health-related quality of life of people with lung diseases.
In October 2014, the FDA approved nintednib, which is marketed as Ofev, for the treatment of idiopathic pulmonary fibrosis (IPF). Because IPF and SSc-ILD share similarities in how fibrosis, or the underlying scarring of the lungs, forms in people with the disease, evaluating the impact of the drug in this indication was justified.
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