Boehringer Ingelheim can now market its drug nintedanib for use in people with a rare lung disease in the EU after winning approval from the European Commission.
Nintedanib will be marketed under the name Ofev to treat people with idiopathic pulmonary fibrosis (IPF), a serious lung disease with a median survival of two to three years after diagnosis. The approval comes two months after the European Medicines Agency (EMA) recommended the drug in this indication.
Nintedanib is one of Boehringer’s brightest prospects in its portfolio although its main sales are expected to be in lung cancer where it is marketed under the name Vargatef.
In became Boehringer’s second cancer drug approved in Europe in November last year when the EC gave the green light for its use in locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) after first-line chemotherapy.
Its ability to heal the lung has translated to IPF, however, giving Boehringer’s portfolio another boost, although the potential market is limited as IPF is thought to affect just 14 to 43 people per 100,000.
The disease is most common in people over the age of 50 and leads to permanent scarring of the lungs and decreases the amount of oxygen the lungs can supply to major organs of the body.
Ofev, which is available as a capsule to be taken twice a day, has demonstrated its effectiveness in the phase III INPULSIS trials involving 1,066 patients with IPF from 24 countries.
According to Beohringer, the drug slowed disease progression by reducing the annual rate of decline in lung function by 50%, while the risk of adjudicated acute exacerbations was reduced by 68%.
Boehringer’s chief medical officer Prof Klaus Dugi said: “This approval is another milestone in Boehringer Ingelheim’s ongoing efforts with regard to innovation in rare diseases in general and our continuing research for the benefit of patients affected by such a dreadful disease as IPF in particular.”
Ofev is also available to treat IPF in the US where it was approved by the FDA in October 2014.