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Boehringer aims for nintedanib approval in lung fibrosis by year end

EMA grants accelerated assessment to drug in rare disease
Boehringer Ingelheim headquarters

Boehringer Ingelheim will get an accelerated assessment of its chronic lung disease drug nintedanib in the EU, setting it on course for possible approval before the end of the year.

Nintedanib is being reviewed by the European Medicines Agency (EMA) as an oral therapy for idiopathic pulmonary fibrosis (IPF), a chronic and fatal disease characterised by progressive decline in lung function due to inflammation and scarring of the tissue surrounding the lungs.

"There is a high unmet need for effective treatments that can slow disease progression [in IPF]," said Boehringer's chief medical officer Klaus Dugi, adding that, in trials, nintedanib has been shown to cut decline in lung function by half.

Boehringer has carried out two year-long studies of nintedanib  - INPULSIS-1 and INPULSIS-2 - that were published in the New England Journal of Medicine's last month. At a dose of 150mg twice-daily, the drug slowed the annual rate of decline in forced vital capacity (FVC) - a measure of lung function - by 50 per cent compared to placebo.

The study also revealed a non-significant trend towards a reduction in the number of acute exacerbations in IPF patients - down 38 per cent compared to placebo - and a significant 68 per cent risk reduction in confirmed or suspected acute exacerbations. Its most common side effect was diarrhoea, which caused around 5 per cent of patients to discontinue therapy.

Nintedanib's primary competitor in the near term is Intermune's Esbriet (pirfenidone), which is already on the market in the EU and Canada, as well as some other countries around the world, and was recently resubmitted for approval in the US.

Analysts have previously suggested that Esbriet could achieve sales of around $500m a year, despite the relatively small IPF market, even if the drug achieves only 25 per cent penetration.

Other companies looking at IPF include Gilead Sciences, which is exploring the use of its simtuzumab (GS-6624) candidate in a subgroup of fast-progressing patients, and Biogen Idec, which has a candidate called STX-100 in phase II. Bristol-Myers Squibb (BMS) and Fibrogen also have compounds in early- to mid-stage development.

While there is no denying nintedanib's importance as an IPF treatment, the greater market potential will likely come from its use in oncology. Boehringer filed for approval of nintedanib as a second-line therapy for non-small cell lung cancer (NSCLC) last year and is developing it for various other tumour types.

Article by
Phil Taylor

5th June 2014

From: Research, Sales, Regulatory



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