Nintedanib Submitted for Regulatory Approval to Treat SSc-ILD in US and Europe

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by Santiago Gisler |

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Boehringer Ingelheim has submitted its proprietary therapy nintedanib to the U.S. Food and Drug Administration and the European Medicines Agency for regulatory approval to treat systemic sclerosis (SSc)-associated interstitial lung disease (SSc-ILD).

Approval is needed by the relevant regulatory agencies before a new product or treatment can reach the market, and is necessary to sell or market new medications.

SSc is characterized by the accumulation of scar tissue in different tissues, including the lungs. About 25 percent of SSc patients develop pulmonary involvement. ILD is a group of lung disorders associated with inflammation and progressive scarring of the lung tissue.

“Systemic sclerosis associated interstitial lung disease has a devastating impact on those it affects – often women in the prime of their lives,” Susanne Stowasser, MD, associate head of respiratory medicine at Boehringer Ingelheim, said in a press release. “Pulmonary fibrosis is a key driver of mortality in systemic sclerosis, and currently there are no approved treatments for SSc-ILD.”

Nintedanib, an approved therapy sold as Ofev for the treatment of idiopathic pulmonary fibrosis (a chronic and progressive lung disease), is a so-called tyrosine kinase inhibitor that blocks a group of growth factor receptors associated with pulmonary fibrosis, a type of ILD. A preclinical study showed that nintedanib reduced fibrosis and blood vessel remodeling (structural changes of the blood vessels) in animal models.

According to the company, clinical research data on the efficacy and safety of nintedanib in patients with SSc-ILD will be presented at the upcoming American Thoracic Society conference in May.

“Boehringer Ingelheim is pleased that we are able to take a step closer to potentially bringing an approved treatment for addressing the decline in lung function to patients with this rare condition,” Stowasser said.

In March 2018, the FDA granted nintedanib a fast track designation, which aids in the development of new therapies fulfilling unmet medical needs. Previously, in 2016, both the FDA and the EMA granted the therapy orphan drug status for the treatment of SSc-ILD.