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Boehringer gets FDA breakthrough status for IPF treatment for nintedanib

Germany-based Boehringer Ingelheim has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational therapy nintedanib to treat idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease.

Currently, nintedanib is under FDA and European Medicines Agency (EMA review) to be indicated for the treatment of IPF.

Boehringer Ingelheim chief medical officer Klaus Dugi said the company is happy that nintedanib has been granted breakthrough therapy designation in the US, which it hopes will make the treatment available to IPF patients as quickly as possible.

"Currently there are no FDA-approved treatments available for IPF. We are committed to working with all regulatory bodies to make nintedanib available to people living with this serious and life-threatening lung disease," Dugi said.

IPF causes permanent scarring of the lungs, difficulty breathing and decreases the amount of oxygen the lungs can supply to the major organs of the body.

The disease affects as many as 14-43 people per 100,000 across the world.

The company said that nintedanib is the first targeted treatment for IPF that has consistently showed to slow disease progression in IPF by significantly reducing the annual decline in lung function by about 50%.