Boehringer Ingelheim‘s product nintedanib (marketed as Ofev for the treatment of idiopathic pulmonary fibrosis) has been granted fast track designation by the U.S. Food and Drug Administration for the treatment of systemic sclerosis associated with interstitial lung disease (SSc-ILD).
Fast track designation is granted to new therapies that are designed for the treatment of serious conditions and that fulfill an unmet medical need. This designation allows the medication to be developed faster through more meetings with the FDA, more frequent communication regarding clinical trials and use of biomarkers, eligibility for accelerated approval, and other benefits.
Systemic sclerosis (Ssc) is a condition that is characterized by fibrosis, or scarring, in the connective tissue of different organs in the body. Most patients with systemic sclerosis will develop some lung fibrosis, called interstitial lung disease (ILD), which is a major cause of death among Ssc patients.
“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,” Robert Riggs, CEO of the Scleroderma Foundation, said in a press release.
Nintedanib’s fast track status was granted based on Boehringer Ingelheim’s investigational new drug (IND) application, along with anticipated data from the phase 3 SENSCIS clinical study (NCT02597933) conducted to determine the safety and effectiveness of nintedanib for the treatment of SSc-ILD.
This pivotal study is fully enrolled, with more than 520 participants from 32 countries.
“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 of 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,” he said.
Nintedanib can block multiple cell pathways that lead to fibrosis. Pre-clinical studies have shown that the drug can reduce fibrosis and blood vessel remodeling in animal models.
Nintedanib was previously granted orphan drug status for the treatment of systemic sclerosis, as well as associated ILD, by both the FDA and the European Commission.