Boehringer Ingelheim’s Jascayd (nerandomilast) tablets have been granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF).
Jascayd is the first treatment of its kind licensed for use in IPF and PPF in adults. The MHRA authorisation is based on the results of the pivotal phase 3 clinical trials involving 1,177 and 1,176 patients with IPF and PPF respectively.
Currently, there is a high unmet need for patients, as there are few treatment options that slow the disease progression, with IPF being described as having a five-year survival rate of just 45.6%, comparable with many cancers. Over 5,000 people in the UK die each year from IPF, which represents around 1 in 100 deaths nationwide.
“The MHRA authorisation of nerandomilast is a meaningful advancement in the management of this condition, where there is high mortality and a substantial impact on quality of life,” commented Douglas Clark, Medical Director of Boehringer Ingelheim UK & Ireland. “We are now working closely with NICE, aiming to bring nerandomilast to eligible patients on the NHS as soon as possible.”
Pulmonary fibrosis is a chronic and ultimately fatal condition characterised by irreversible lung scarring and a continuous decline in lung function. Symptoms include worsening breathlessness, a persistent dry cough and fatigue. Antifibrotics have been the mainstay of treatment for the past decade, with no effective treatment innovations licensed since then.
“A diagnosis of progressive pulmonary fibrosis means that life expectancy is reduced while day-to-day quality of life can often deteriorate, as breathlessness and fatigue worsen,” commented Professor Philip Molyneaux, Consultant Respiratory Physician and Professor of Interstitial Lung Disease at Imperial College London. “With the authorisation of nerandomilast by the MHRA, clinicians have a new treatment option that can slow the decline in lung function, expanding the choices available for eligible patients.”
NICE is evaluating Jascayd to treat adults with IPF or PPF, with guidance expected in September 2026.