CHMP recommends approval of nintedanib in systemic sclerosis-associated interstitial lung disease.- Boehringer

Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting marketing authorisation for nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults. In September, the U.S. Food and Drug Administration (FDA) approved nintedanib as the first and only medicine to slow the rate of decline in pulmonary function in adults living with SSc-ILD. Regulatory approvals for the treatment of patients living with SSc-ILD have also been granted in other countries including Canada, Japan and Brazil. The positive opinion was based on the results of the SENSCIS trial, a phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of nintedanib in patients with ILD-associated systemic sclerosis (SSc-ILD). The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC) assessed over a 52-week period. Patients remained on the study treatment for at least 52 weeks of treatment or for a maximum of 100 weeks of treatment. Results showed nintedanib slowed the loss of pulmonary function by 44% (41mL/year) relative to placebo, as measured in FVC over 52 weeks. The adverse-event profile of nintedanib was similar to that observed in patients with idiopathic pulmonary fibrosis, with the most common adverse event being diarrhoea.