Boehringer nets FDA’s approval for Ofev for slowing decline in pulmonary function with SSc-ILD patients

Boehringer Ingelheim bagged the FDA’s approval for Ofev (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

The company noted that Ofev is already approved in the U.S. and more than 70 countries for the treatment of idiopathic pulmonary fibrosis (IPF).

Thomas Seck, senior vice president at Boehringer Ingelheim Pharmaceuticals was quoted to say in a press release that this is the first FDA-approved therapy to slow the rate of decline in pulmonary function for systemic sclerosis-associated interstitial lung disease and provides hope to patients and their loved ones facing this devastating disease. He said: “This approval is supported by positive evidence from the Phase III study that showed Ofev significantly slowed the progression of lung function decline in this patient population and exemplifies Boehringer Ingelheim’s dedication to the rare disease community.”

Largest SSc-ILD study to date
Boehringer said that the approval was based on results of SENSCIS^®, a Phase III double-blind randomized, placebo-controlled trial, that involved 576 patients from 194 trial sites across 32 countries. The primary endpoint was the annual rate of decline in FVC in patients with SSc-ILD. Results show that Ofev slowed the loss of pulmonary function by 44% (41 mL/year) in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks.

“An approved anti-fibrotic medication for this condition is a scientific advancement in the care of patients living with this rare disease,” said Kristin Highland, M.D., pulmonologist with the Cleveland Clinic. “The option to offer a new therapy is welcome news for doctors and their patients.”