Boehringer Ingelheim has revealed the data behind its recent filing for nintedanib in rare disease systemic sclerosis (SSc), revealing a significant reduction in the loss of lung function with the drug.
Nintedanib – sold as Ofev for idiopathic pulmonary fibrosis (IPF) and Vargatef for and some types of non-small cell lung cancer (NSCLC) – is one of Boehringer’s most important growth products and was filed for interstitial lung disease (ILD) in SSc patients in both the US and Europe in February and March, respectively.
If approved, SSc would become the third indication for the drug and would lend additional momentum to its already buoyant growth, with sales rising a third to €1.1bn last year.
That’s important for Boehringer, as the German drugmaker is looking to the product to prop up its respiratory franchise as sales of its chronic obstructive pulmonary disease (COPD) and asthma blockbuster Spiriva (tiotropium) decline in the face of greater competition and pricing pressure.
While classed as a rare disease, there are an estimated 2.5m people worldwide with SSc – also known as scleroderma – which is characterised by thickening and scarring or fibrosis of connective tissue throughout the body.
Around 80% of patients go on to develop ILD, and this is one of the leading causes of death in SSc patients with no approved therapies.
In the phase 3 SENSCIS trial published in the New England Journal of Medicine this week and presented at the American Thoracic Society Conference in Dallas, SSc-ILD patients taking nintedanib showed a 44% reduction in the rate of decline of their lung function, measured by forced vital capacity (FVC) over 52 weeks.
In absolute terms, by the end of the trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC of -52.4 ml/year with nintedanib, versus -93.3 ml/year with placebo.
Professor Toby Maher, Professor of Interstitial Lung Disease, National Heart and Lung Institute, Imperial College, London, and SENSCIS steering committee member said: “Today’s findings are extremely important, particularly given that there are currently no approved treatments for this condition, which disproportionately affects women, and especially those between 25 and 55 years old.”
He added: “A 44% reduction in lung function decline represents a significant slowdown in the development of irreversible fibrosis of the lung. Nintedanib has the potential to make a big difference to the lives of people with this rare, life-shortening disease.”
Dr Juliet Roberts, Medical Director, UK & Ireland, Boehringer Ingelheim said: “Clinical trials should always address an important scientific question with patient needs as a priority. We are proud that this trial not only contributes to the evidence base in an area of clear unmet medical need, but was also designed with the support and input of scleroderma patient organisations from many countries.”