EU approves Jascayd as first new IPF oral treatment in a decade

The oral therapy Jascayd (nerandomilast) has been approved in the European Union for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).

The marketing authorization from the European Commission follows a positive recommendation from a regulatory committee and marks the first new IPF therapy approved in the EU in more than a decade, according to developer Boehringer Ingelheim.

“With JASCAYD, physicians across the EU gain a long-awaited, new treatment option for people living with IPF and PPF that is effective, has a well-characterized safety profile and may support long-term adherence,” Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim, said in a company press release. “This milestone is a major advancement, but it must also be a catalyst for broader recognition that lungs can’t wait. Earlier recognition and diagnosis of pulmonary fibrosis are crucial because for people living with a progressive disease, every moment matters.”

Pulmonary fibrosis refers to scarring in the lungs, which makes it harder for the lungs to take in oxygen and leads to symptoms such as shortness of breath and coughing. The most common form of pulmonary fibrosis is IPF, whose underlying cause is unknown. Meanwhile, PPF is marked by gradually worsening lung scarring that may be triggered by other underlying diseases or exposure to inhaled substances.

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Understanding how Jascayd works in the body

IPF and PPF collectively affect more than nine million people worldwide, including more than 500,000 people across Europe, according to Boehringer Ingelheim.

Jascayd works to reduce lung inflammation and scarring by blocking the activity of an enzyme called phosphodiesterase 4B. The oral therapy was previously approved in the U.S. and in Japan for IPF and PPF.

Approval in Europe was based mainly on data from two Phase 3 clinical trials, both of which tested the therapy against a placebo. One study, FIBRONEER-IPF (NCT05321069), enrolled more than 1,000 adults with IPF, while the other, FIBRONEER-ILD (NCT05321082), enrolled more than 1,000 adults with PPF. Across both trials, results showed that Jascayd outperformed the placebo at slowing lung function decline, with trends suggesting the therapy also reduced the risk of death.

Common side effects of Jascayd include diarrhea, COVID-19, upper respiratory tract infection, depression, weight loss, decreased appetite, nausea, vomiting, fatigue, headache, dizziness, and back pain. In the FIBRONEER trials, patients taking Jascayd as a standalone therapy stopped treatment at rates similar to those taking the placebo. Notably, unlike some other pulmonary fibrosis treatments, Jascayd does not require regular monitoring of liver health.

“One of the challenges of managing IPF and PPF is seeing patients needing to stop treatment early because the side effects are too much to tolerate,” said Marlies Wijsenbeek, MD, PhD, a lung specialist at the Erasmus MC University Medical Center in the Netherlands. “The FIBRONEER trials showed us that [Jascayd] preserves lung function with a tolerability profile that allows patients to stay on their medication, which is a major clinical advancement that patients across the EU have been waiting for. Also, removing the burden of ongoing liver monitoring is an additional improvement for patients.”

Impact on European patient communities

Sue Farrington, president of the Federation of European Scleroderma Associations, said the approval of Jascayd in the EU brings welcome news for the community and “offers renewed hope for people living with systemic sclerosis and other diseases that can lead to progressive lung fibrosis.”

“When diagnosed with a progressive and irreversible lung condition like IPF or PPF, your greatest fear is running out of treatment options,” Farrington said. “Having a therapy that patients can reliably stay on to preserve their lung health brings real stability and hope to families.”