FDA expands label for Boehringer Ingelheim's Ofev to include chronic fibrosing ILDs with progressive phenotype

Boehringer Ingelheim on Monday announced that the FDA approved Ofev (nintedanib) as the first treatment for patients with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. The multi-targeted tyrosine kinase inhibitor is currently approved in the US to treat idiopathic pulmonary fibrosis (IPF) and to slow the rate of pulmonary function decline in patients with systemic sclerosis-associated ILD (SSc-ILD).

Thomas Seck, the company's senior vice president of medicine and regulatory affairs, commented that the "approval marks a major advancement in ILD research and is an important milestone just six months after the approval of Ofev to slow the rate of decline in pulmonary function in patients with SSc-ILD."

The latest approval was based on data from the Phase III INBUILD trial evaluating twice-daily Ofev in 663 patients with chronic fibrosing ILDs with a progressive phenotype. Results from the 52-week study showed that Ofev slowed the loss of pulmonary function by 57% across a range of patients compared with placebo. Among those found to have a usual interstitial pneumonia-like fibrotic pattern on high-resolution computerised topography, treatment with Ofev versus placebo slowed the loss of pulmonary function by 61%. The results also showed that Ofev's safety and tolerability profile was consistent with what was previously seen in IPF studies, with the most common adverse reaction being diarrhoea.

The drug was granted an FDA breakthrough designation for chronic fibrosing ILDs with progressive phenotype last October.

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