European Regulators Grant Boehringer’s Nintedanib Accelarated Assessment

European Regulators Grant Boehringer’s Nintedanib Accelarated AssessmentBoehringher Ingelheim have announced the successful marketing authorisation application for nintedanib, and confirmed that Europe’s regulatory body, the European Medicines Agency (EMA), will commence an accelerated assessment of the drug for the treatment of the fatal lung disease idiopathic pulmonary fibrosis (IPF).

“IPF is a relentless and fatal lung disease, and there is a high unmet need for effective treatments that can slow disease progression,” Professor Klaus Dugi, Chief Medical Officer at Boehringer commented.

The marketing application for nintedanib included data from two Phase III clinical trials (INPULSIS-1 and INPULSIS-2).  Results from the clinical trials showed that the tyrosine kinase inhibitor (TKI) significantly held back disease progression, reducing the annual decline in forced vital capacity (FVC) by 50% when compared to placebo over 52 weeks.

Nintedanib, which is taken as two capsules per day, is the first targeted treatment for IPF patients which has constantly demonstrated slowing disease progression by significantly reducing the decline in lung function by half, with a manageable side effect profile.

The European Medicines Agency is also currently reviewing nintedanib as a second-line therapy for non-small cell lung cancer (NSCLC).

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