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Boehringer's TKI inhibitor Ofev gets FDA approval for chronic fibrosing interstitial lung diseases with a progressive phenotype

The FDA has green-lit Boehringer Ingelheim’s multi-targeted tyrosine kinase inhibitor Ofev (nintedanib) in the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, it has emerged.

The FDA made its judgement on the back of Phase 3 data drawn from the first ILD study to focus on the clinical behaviour of the disease rather than primary clinical diagnosis, and group patients according to these criteria.

Boehringer's Ofev scores first-of-its-kind FDA approval in rare lung disease

Boehringer Ingelheim’s Ofev (nintedanib) capsules have now secured marketing authorisation in the US, it has emerged, for the treatment of interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD), a rare lung condition.

The decision, made under the FDA’s Priority Review pathway, was supported by data which demonstrated that the drug reduced lung function decline compared to placebo, and makes Ofev the first and only FDA-approved therapy to slow the rate of decline in this condition,

Boehringer launches IPF initiatives

Boehringer Ingelheim has launched a collaborative initiative aimed at raising awareness and understanding of the rare lung disease Idiopathic Pulmonary Fibrosis (IPF).

Working with pharmaphorum media, the company brought together patients, patient groups and globally renowned clinicians to launch a report into IPF called Inspiration – the results of which have been launched on Rare Disease Day 2016. Boehringer has also launched the Inspiration magazine, which aims to give patients a voice and put the debilitating condition in the spotlight.

Boehringer’s OFEV slows IPF disease progression by half in trials

Boehringer Ingelheim has revealed pooled analysis data from three trials, showing that its drug OFEV significantly reduces the risk of acute exacerbations by 47% in people with the rare lung disease idiopathic pulmonary fibrosis (IPF).

An acute exacerbation is the name given to a sudden unexplained worsening in respiratory function - a leading cause of hospitalisation IPF patients.

Boehringer widens IPF drug’s reach

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Boehringer Ingelheim has highlighted new data for its idiopathic pulmonary fibrosis (IPF) treatment Ofev in a Phase II study on a broader range of patients. 

The German firm presented its findings in the US at the Am

Boehringer assures future growth following sales drop

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Boehringer says it is positioned for future growth in the wake of filing a decline in profit for 2014 and flat earnings.

Its latest annual financial statement reports that net income dropped 21% to €1.05 billion ($1.13 billion) last year from €1.32 billion in fiscal 2013. Global sales declined 5.3% to €13.3 billion. Full-year operating profit came in at €2.1 billion the German family-owned group notes.

Boehringer eyes Ofev success in IPF and beyond

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Experts say the launch of Boehringer Ingelheim’s new treatment for idiopathic pulmonary fibrosis (IPF) offers stiff competition to Roche’s Esbriet that serve to ultimately benefit patients.

Boehringer launches Ofev (nintedanib) in the EU this week seeing the firm go head to head with Roche’s Esbriet (pirfenidone) – the only drug approved by NICE for use as a treatment for IPF in the NHS.

Boehringer gains EU approval for Ofev

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The European Commission has approved Boehringer Ingelheim’s Ofev as a treatment for idiopathic pulmonary fibrosis (IPF).

The approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) giving the drug a positive opinion in November last year, following an expedited EMA review.

Boehringer’s lung cancer drug Vargatef sees EU approval

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Boehringer Ingelheim’s nintedanib has received its second nod in Europe this month with the European Commission approving it for the treatment of lung cancer.

The drug will be marketed as Vargatef and is indicated for the treatment of non-small cell lung cancer (NSCLC) adenocarcinoma after first-line chemotherapy, when used in combination with docetaxel.

CHMP nods several drugs through

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Ten new medicines have been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), among them breakthrough IPF drug Ofev.

Boehringer Ingelheim’s Ofev (nintedanib) is one of only two drugs currently available in the world for the treatment of idiopathic pulmonary fibrosis (IPF), a fatal lung diseases characterised by scarring of the lung tissue.

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