Boehringer Ingelheim gets EC approval for nintedanib to treat SSc-ILD

Boehringer Ingelheim has secured approval from the European Commission (EC) for its nintedanib to treat systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adult patients.

Systemic sclerosis (SSc), also called as scleroderma, is a disfiguring, disabling and fatal rare autoimmune disease.

Nintedanib is a tyrosine kinase inhibitor designed to target crucial receptors engaged in signalling pathways that may cause pulmonary fibrosis.

The approval was based on data from the SENSCIS phase III double-blind and placebo-controlled study carried out to assess the efficacy and safety of nintedanib in patients with SSc-ILD.

The SENSCIS randomised controlled trial recruited 576 patients across over 32 countries, including the US, Canada, China, Japan, Germany, France and the UK.

According to the company, the primary endpoint was the annual rate of decline in forced vital capacity (FVC) evaluated over 52 weeks and the results demonstrated nintedanib delayed the loss of pulmonary function by 44 relative to placebo.

The company also secured regulatory approvals for nintedanib in various countries, including Canada, Japan, and Brazil, to treat patients living with SSc-ILD.

Boehringer secured approval for nintedanib to treat idiopathic pulmonary fibrosis (IPF) in more than 75 countries.

In September 2019, the company secured approval from the US Food and Drug Administration (FDA) to delay the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD.

The FDA also granted breakthrough therapy designation and subsequent approval to treat chronic fibrosing interstitial lung diseases with a progressive phenotype in March this year.

Boehringer Ingelheim inflammation therapeutic area head and senior vice president Peter Fang said: "Once fibrosis of the lungs occurs it cannot be reversed. Nintedanib, being the first and only approved treatment for SSc-ILD, is serving a high unmet need making a real positive difference to those living with this life-changing condition.

"The approval is a further milestone in Boehringer Ingelheim’s ongoing dedication for people living with pulmonary fibrosis."

In March this year, Boehringer and Eli Lilly have secured fast track status from the US Food and Drug Administration (FDA) for the investigation of Jardiance (empagliflozin) to treat chronic kidney disease.
 

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