The European Commission has approved Boehringer Ingelheim’s Ofev (nintedanib) to treat the lung-scarring disease idiopathic pulmonary fibrosis, providing patients with a new treatment option.
Approval came on the back of clinical data from the Phase III INPULSIS trials, which showed that the drug slowed disease progression through a 50% reduction lung function decline over a year across a broad range of IPF patient types.
The twice daily pill is the first targeted treatment for IPF to consistently meet the primary endpoint in two identically designed Phase III trials, BI claims, also noting that it significantly reduces the risk of adjudicated acute exacerbations by 68%.
IPF is a debilitating and fatal lung disease which has a median survival of two-three years after diagnosis and patients have limited treatment options. Ofev will now join Roche’s Esbriet (pirfenidone) - approved in Europe in 2011 - on the IPF market.
“It’s great that there is now a choice of treatments for IPF patients. This approval provides important hope for patients and caregivers living with this awful disease,” noted Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom.
BI’s drug was also cleared for lung cancer in Europe, under the trade name Vargatef, in November last year.