Health Canada approves new oral treatment option for IPF and PPF
Jascayd shown to slow lung function decline in 2 Phase 3 clinical trials
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Health Canada has approved Boehringer Ingelheim‘s oral therapy Jascayd (nerandomilast) as a treatment for adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
“The authorization of JASCAYD marks an important milestone for patients, caregivers and healthcare professionals,” Rasha Eldesouky Abouelabbas, vice president of medical and regulatory affairs at Boehringer Ingelheim (Canada), said in a company press release announcing the approval.
“We are proud to bring a new treatment option to Canadians living with IPF and PPF and remain committed to advancing lung health innovation for people affected by serious lung diseases,” Abouelabbas added.
Jascayd targets lung scarring in IPF and PPF
IPF and PPF both cause fibrosis (scarring) in the lungs. This makes it harder for the lungs to take in oxygen, leading to symptoms such as shortness of breath. The underlying cause of IPF is unknown. PPF refers to other lung diseases in which scarring gets progressively worse over time.
Jascayd is taken twice daily, with or without food. It works by blocking an enzyme called phosphodiesterase 4B (PDE4B), which is thought to contribute to inflammation and scarring in the lungs of people with IPF and PPF. Canada’s approval follows a similar decision in the European Union. Jascayd is also approved for IPF and PPF in the U.S.
Jascayd’s approvals were supported by two Phase 3 clinical trials: FIBRONEER-IPF (NCT05321069), in people with IPF, and FIBRONEER-ILD (NCT05321082), in people with PPF. Both studies met their primary goals. Jascayd slowed the decline in forced vital capacity (FVC), a measure of how much air a person can forcefully breathe out, compared with a placebo. Death rates were numerically lower among patients receiving Jascayd than among those receiving placebo, although neither trial met its key secondary endpoint.
According to Boehringer Ingelheim, Jascayd is the first new treatment approved in Canada for IPF in more than a decade and for PPF in more than five years.
“People living with pulmonary fibrosis have waited more than a decade for a new treatment option. During that time, patients and families have faced the daily challenges of a disease that affects their independence, quality of life and plans for the future,” said Sharon Lee, CEO of the Canadian Pulmonary Fibrosis Foundation (CPFF).
“The authorization of JASCAYD brings renewed hope to our community. We are grateful to the researchers and clinical trial participants who made this advancement possible, and we will continue working toward equitable access for Canadians who need it,” Lee added.
Common adverse reactions reported in Jascayd clinical trials included COVID-19 and upper respiratory tract infections, as well as diarrhea, nausea, vomiting, loss of appetite, and weight loss. Depression, fatigue, back pain, headache, and dizziness were also commonly reported.
Martin Kolb, MD, PhD, a professor at McMaster University in Ontario, said the approval of Jascayd in Canada “is welcome news and provides an important new and better tolerated treatment option for patients living with IPF and PPF.”
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