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FDA clears wider use for Boehringer’s Ofev in lung disease

Drug was first approved in 2014 for pulmonary fibrosis


Boehringer Ingelheim has snared another approval for its pulmonary fibrosis drug Ofev from the US Food and Drug Administration (FDA), this time capturing a wider spectrum of patients with interstitial lung disease (ILD).

The regulator has approved Ofev (nintedanib) for treating chronic fibrosing ILDs with a progressive phenotype, and Boehringer’s drug is the first to be registered in the US for patients with this form of lung disease.

Ofev was first approved to treat idiopathic pulmonary fibrosis (IPF) in 2014, and last year its uses were extended to include patients with ILD caused by systemic sclerosis (SSC-ILD), a rare autoimmune disease that affects around 100,000 people in the US.

Analysts have previously suggested that the market potential for SSc-ILD on its own could be almost as big as IPF. The new indication means it can now be used to treat progressive ILD resulting in scarring of the lungs that stems from a range of causes, unlocking an even larger eligible patient population for the drug.

The new label applies to between 18% and 32% of patients with around 200 separate disorders, including  “unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, Sjogren's syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias”, says Boehringer.

In severe forms, ILDs can reduce life expectancy by three to five years, with the chronic loss of lung function sometimes complicated by other symptoms such as pulmonary hypertension and heart failure, so having a treatment option will be a lifeline for patients.

Ofev is already a blockbuster seller for Boehringer, growing almost 29% to reach €1.1bn in 2018 from its use in IPF. Privately-held Boehringer hasn’t reported 2019 financial figures yet, but said in the first half of last year the drug grew 22% to €677 million, ahead of the approval in SSC-ILD last September.

The drug has been approved in the wider ILD population on the strength of a phase 3 clinical trial – called INBUILD – which showed that Ofev slowed lung function decline by 57% compared to placebo, measured by the annual rate of decline in forced vital capacity (FVC) in 663 patients.

FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

Ofev is the flagship product in Boehringer’s fibrosis franchise, but the German drugmaker is investing considerably in R&D in this category.

Earlier this year it signed a wide-ranging. Multibillion-euro deal with Enleofen for IL-11 inhibitors with potential in fibrotic diseases affecting the lungs, liver and other organs, and that followed earlier deals with Bridge Biotherapeutics for an Ofev follow-up and Yuhan focusing on lover fibrosis.

Article by
Phil Taylor

10th March 2020

From: Regulatory



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