EMA accepts Boehringer IPF drug
pharmafile | June 6, 2014 | News story | Sales and Marketing | Boehringer, EMA, IPF, inpulsis, lung, nintedanib
Boehringer Ingelheim has moved a step closer to getting its investigational treatment nintedanib approved in Europe for a potentially fatal lung disease.
The European Medicines Agency has accepted nintedanib (also known as Inpulsis) for accelerated review in idiopathic pulmonary fibrosis (IPF).
In the US, the Food and Drug Administration has already given nintedanib orphan designation which increases its patent life, and analysts are predicting blockbuster sales for the drug.
In results published last month in the New England Journal of Medicine, nintedanib reduced annual decline in lung function by half although it does not reverse damage from IPF.
“IPF is a relentless and fatal lung disease, and there is a high unmet need for effective treatments that can slow disease progression,” says Klaus Dugi, Boehringer’s chief medical officer.
In two 52-week Phase III trials, INPULSIS-1 and INPULSIS-2, two nintedanib capsules per day reduced the annual decline in forced vital capacity by 50% compared to placebo.
Boehringer says it is “committed to making nintedanib available to patients with IPF and is prepared to respond to requests for compassionate use, subject to local regulations”.
The company also wants to shore up nintedanib’s earning potential by adding several cancer licences to its indication in the coming years – it knows the tyrosine kinase inhibitor (TKI) already has competition in the IPF market.
InterMune has announced that it would give its own IPF treatment pirfenidone to some US patients at no cost, a decision that may help kick-start sales of the product.
The medicine did receive approval in Europe, where it is known as Esbriet, in 2011 at a cost of around $21,000 per patient.
The FDA rejected it the same year due to the need for more clinical trial data – but the firm says it will now resubmit its latest data to the FDA in the hope of an approval. Analysts predict Esbriet can reach in excess of $1 billion in peaks sales.
Adam Hill
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