InterMune scores in lung trial
pharmafile | February 26, 2014 | News story | Research and Development, Sales and Marketing | Esbriet, FDA, IPF, InterMune, fvc, lung
InterMune has taken another step on its lengthy road to get the US regulator to approve its drug Esbriet for idiopathic pulmonary fibrosis (IPF) with positive top-line results from a new Phase III trial.
Three years ago, Esbriet (pirfenidone) was the first ever treatment for the potentially fatal lung disease to be approved in Europe.
Although tipped to be a blockbuster, thanks to its high cost and first-in-class status to treat the rare condition, Esbriet has been knocked back by the US Food and Drug Administration.
But now the US company hopes that the ASCEND trial, in which Esbriet significantly reduced IPF disease progression, will mean the FDA has to reconsider this year.
“Based on the strength of the ASCEND results, InterMune is preparing a resubmission of our New Drug Application for pirfenidone to the…FDA, which we expect to submit by early third quarter of this year,” said InterMune chief executive Dan Welch.
IDF is a progressive disease in which the patient’s lungs become thickened and scarred by the build up of excessive collagen. This obstructs the entry of oxygen into the bloodstream, causing severe respiratory problems.
It mostly affects people between 50 and 75 years old. Some patients remain stable for years, but many deteriorate rapidly and live just three to five years after diagnosis.
InterMune estimates that more than 100,000 patients suffer from IPF in the ten most populous European countries, and 87,000 of these live in Germany, France, Spain, Italy and the UK.
When it comes to assessing the drug’s effectiveness, a patient’s forced vital capacity (FVC) – that is, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – is a key measure.
A 10% decline in FVC is considered clinically meaningful and strongly predicts death.
At Week 52 of ASCEND, 16.5% of patients in the Esbriet group experienced an FVC decline of 10% or more or death – compared with 31.8% in the placebo group (a 47.9% reduction).
At the same point, 22.7% of Esbriet patients experienced no decline in FVC, compared with 9.7% taking placebo (a 132.5% increase).
The trial also fulfilled secondary endpoints, such as the six-minute walk distance (6MWD) and progression-free survival (PFS).
Change from baseline to Week 52 in 6MWD is measured and a 50-metre or more drop in walk distance is considered another independent predictor of mortality – and Esbriet reduced by 27.5% the proportion of patients who experienced this decline.
In ASCEND, the drug also reduced the risk of death or disease progression by 43% compared to placebo – a PFS event being defined as either death, 10% drop in FVC or 6MWD decrease of 50 metres.
InterMune is to present additional data from ASCEND at the 2014 American Thoracic Society International Conference in May.
For now the manufacturer has the IPF field to itself, but it will be aware that Boehringer Ingelheim is developing its own IPF treatment.
However, Esbriet’s orphan drug status in Europe gives it ten years of marketing exclusivity lasting until 2021. InterMune also has numerous patent applications in Europe relating to Esbriet and its formulation which the company says will provide patent protection in Europe until 2030.
Adam Hill
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