Boehringer’s Jascayd becomes first new IPF treatment in US for a decade

Credit: JHVEPhoto / Shutterstock.com

The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Jascayd (nerandomilast) for idiopathic pulmonary fibrosis (IPF).

The greenlight from the regulator makes Jascayd the first new treatment to be licensed in the US for the rare lung condition in more than 10 years.

The FDA backed Jascayd at a recommended dosage of 18mg orally twice a day, with a dosage reduction – for intolerability – to 9mg twice daily, except in patients also taking pirfenidone.

The treatment’s approval was supported by Boehringer’s two FIBRONEER phase III clinical trials of adults with IPF.

Their primary endpoint was absolute change from baseline in Forced Vital Capacity (FVC) – the maximum amount of air a person can forcefully exhale after taking the deepest possible breath, and trial participants taking Jascayd had a significantly smaller FVC decline when compared with placebo-treated patients. The studies also found the drug to be well tolerated, with discontinuation rates that were comparable to placebo.

Jascayd is an inhibitor of phosphodiesterase 4B (PDE4B) that was previously granted Breakthrough Therapy Designation by the FDA for the treatment of IPF and for progressive pulmonary fibrosis, with its IDF indication subsequently received a priority review from the US regulatory.

Idiopathic pulmonary fibrosis and Jascayd

IPF is a rare, serious and progressive disease with no cure and limited treatments that develops when the lung tissue surrounding the air sacs, or alveoli, in the lungs becomes thick and stiff. Over time, these changes can cause permanent lung scarring (fibrosis) that makes it more difficult to breathe.

Many people with IPF, which is most often diagnosed in those aged 60 to 70 years old, also experience acute exacerbations, in which symptoms suddenly intensify.

Jascayd is also seeking an authorisation from regulators in progressive pulmonary fibrosis and is in phase II trials for systemic sclerosis. Meanwhile, for IPF it has also been submitted for approval to regulatory authorities in the European Union, China and Japan.