Boehringer Ingelheim recently announced that the British National Institute for Health and Care Excellence (NICE) has recommended OFEV (nintedanib) as a therapy for adult patients with idiopathic pulmonary fibrosis (IPF) within the National Health Service (NHS) in England and Wales.
The recommendation can be viewed at www.nice.org.uk/guidance/TA379.
IPF is a debilitating disease identified by progressive scarring of the lung tissue that leads to deterioration in lung function. The loss of lung functionality is measured in terms of a decline in the patient’s forced expiratory volume (forced vital capacity, FVC), the maximum volume of breath that can be exhaled during a forced breath. More than 5,000 people are diagnosed with IPF every year in the United Kingdom.
There is no cure for IPF, but a limited number of medications are currently on the market that can reduce symptoms, slow disease progression, prevent acute exacerbations and extend survival. These medications have different efficacies, side effects, and survival rates.
OFEV is an oral medication composed of a small molecule tyrosine kinase inhibitor (TKI), which acts on growth factor receptors involved in the mechanism of IPF. It is believed that OFEV’s mechanism of action takes place through the inhibition of three TKIs, which may grant OFEV a better efficacy in the treatment of IPF.
The NICE recommendation comes as a result of clinical evidence gathered from three multicenter clinical trials: two Phase 3 trials (INPULSIS 1 and INPULSIS 2) and a Phase 2b dose-ranging trial (TOMORROW). The three trials compared nintedanib with a placebo for 52 weeks in IPF patients age 40 and older.
The results showed that OFEV substantially reduced the rate of FVC decline in IPF patients, and decreased the risk of occurrence of one or more exacerbations when compared to the placebo. OFEV was shown to be the first targeted treatment for IPF to achieve its primary endpoint in two international Phase 3 trials designed alike.
“This NICE recommendation for OFEV is very welcome news for patients in England and Wales who have this devastating disease, as it gives doctors a much needed new option in the management of IPF,” At Boehringer Ingelheim, we have over 90 years of experience in the field of respiratory medicine and are delighted to be leading the way in bringing this novel medicine to people with IPF,” said Professor Klaus Dugi, Boehringer Ingelheim’s medical director and managing director in the U.K. and Ireland, in a press release.
“Having been involved in the NICE appraisal process, Action for Pulmonary Fibrosis is very pleased that nintedanib has been approved for the treatment of patients with IPF. With no cure and very limited treatment options, nintedanib offers an alternative therapy which will be much welcomed by patients,” said Mike Bray, chairman of Action for Pulmonary Fibrosis, a support group for IPF patients and their families in the U.K.