Boehringer’s nintedanib approved in Europe for systemic sclerosis-associated interstitial lung disease
pharmafile | April 22, 2020 | News story | Research and Development, Sales and Marketing | Boehringer Ingelheim, EU, nintedanib, pharma
The European Commission has moved to authorise Boehringer Ingelheim’s nintedanib in Europe for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adult patients, it has emerged.
The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use at the end of February. It also comes on the heels of an FDA approval in September last year, meaning the drug has now been approved in 15 countries including Japan, Canada and Brazil.
SSc, or scleroderma, is a rare autoimmune disease that can cause scarring of organs including the heart, lungs, kidneys and digestive tract, potentially leading to serious complications and even death.
The approval was awarded based on Phase 3 data which demonstrated a reduction in the rate of pulmonary function loss by 44% in nintedanib patients compared to those on placebo over 52 weeks, as measured in forced vital capacity. The drug was also found to be comparable in terms of safety to that observed in idiopathic pulmonary fibrosis patients.
“This is a real breakthrough in the treatment of people living with SSc-ILD,” said Peter Fang, Senior Vice President and Head of Therapeutic Area Inflammation at Boehringer Ingelheim. “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.”
Matt Fellows
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