03 Apr FDA Grants Fast Track Designation to Nintedanib for Scleroderma with Lung Disease
MedicalResearch.com Interview with:
Dr. Thomas Leonard, Ph.D.
Executive director, Clinical Development and Medical Affairs, Specialty Care
MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by systemic sclerosis? What are the disease symptoms and manifestations?
Response: The FDA recently granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with interstitial lung disease (SSc-ILD) – paving the way for Boehringer Ingelheim to take an important step in advancing this potential therapy for those affected by this disease. The designation was based on Boehringer Ingelheim’s Investigational New Drug application (IND) and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled global Phase III trial which is fully enrolled and includes more than 520 patients from 32 countries.
The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner, like those living with systemic sclerosis.
Systemic sclerosis, also known as scleroderma, is a rare disease characterized by thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. 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 with systemic sclerosis.
Nintedanib, currently marketed as Ofev®, is approved for treatment of a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSc-ILD.
MedicalResearch.com: How does nintedanib differ from other treatment for this disease?
Response: There are currently no FDA-approved treatment options for systemic sclerosis, or scleroderma, with lung involvement, and very few drugs have been assessed in clinical trials. Given the proven anti-fibrotic efficacy of nintedanib in idiopathic pulmonary fibrosis patients, who present with lung fibrosis similar to SSc-ILD patients, we initiated the SENSCIS trial to determine the efficacy and safety of nintedanib in those with SSc-ILD.
MedicalResearch.com: What should readers take away from your report?
Response: Boehringer Ingelheim is committed to advancing the development of this potential therapy and addressing the significant unmet medical need for SSc-ILD, as no FDA-approved treatment options currently exist. The Fast Track designation is an encouraging step in Boehringer Ingelheim’s ongoing research to get treatments to those in need sooner and we are looking forward to working with the FDA throughout the development and review process.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: To provide some additional information on SENSCIS™: the study is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of nintedanib 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 people’s skin thickness, 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. The study is fully enrolled. Clinical trial information is available here or by visiting www.clinicaltrials.gov, ID NCT02597933.
– Fast Track designation facilitates development of new therapies that treat serious conditions and fulfill an unmet medical need
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