These approvals, by the U.S. Food and Drug Administration (FDA) and Health Canada, come on the heels of findings from the INBUILD Phase 3 trial (NCT02999178), in which Ofev slowed the rate of lung function decline by 57% across a range of patients compared with placebo.
Ofev is the first medication approved in both countries for ILD patients whose chronic fibrosis continues to worsen over time.
“Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now,” Banu Karimi-Shah, MD, acting deputy director of the division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in an agency press release.
Ofev eases lung tissue scarring (fibrosis) by interfering with signaling pathways that are overly active in patients with lung fibrosis and support the growth of fibroblasts, cells involved in the formation of scar tissue. It is already approved to treat idiopathic pulmonary fibrosis (IPF) and scleroderma-associated ILD.
INBUILD examined the benefits of Ofev in 663 adults with progressive fibrosing ILDs — a group of over 200 conditions that may lead to scarring in the lungs, other than IPF.
Enrolled patients who were randomly assigned to either a 150 mg Ofev or a placebo capsule, taken twice-a-day for one year (52 weeks).
The trial’s primary goal was the annual rate of lung function decline in these two patient groups, assessed through changes in forced vital capacity (FVC, the amount of air a person can exhale after a deep breath) at week 52.
Secondary measures included changes in health-related quality of life, the time patients went before an acute exacerbation, and time to death.
Results showed that INBUILD met its primary goal, with patients on Ofev recording a 57% slower decline in lung function compared with those on placebo. The placebo group experienced an 187.8 mL yearly reduction in their FVC, while patients in the Ofev group lost about 80.8 mL over the year.
Treatment also showed a trend toward a better health-related quality of life, a delay in the time to acute exacerbations or death, and fewer deaths due to any cause, but these measures did not reach statistical significance.
Importantly, the benefits across primary and secondary endpoints were seen regardless of the lung tissue scarring pattern seen in high-resolution computed tomography chest scans.
“Progressive fibrosing ILDs have a significant impact on patients, including worsening lung function and lessening quality of life,” Martin Kolb, clinical investigator in INBUILD, said in another press release. “With this new indication, we now have a therapeutic option to help improve outcomes in ILD patients across the spectrum.”
Ofev’s safety and tolerability was consistent with what was seen in prior IPF clinical trials. The most common adverse event was diarrhea, which was more common among patients taking Ofev than those on a placebo.
The “Canadian Pulmonary Fibrosis Foundation (CPFF) is pleased to see a treatment for patients with progressive fibrosing ILD (PF-ILD), which often leads to irreversible damage to their lungs and makes it difficult to breathe and do everyday tasks,” said Sharon Lee, its executive director.
“Canadian patients with progressive ILDs now have access to a therapeutic option and the hope it brings to focus on life beyond their diagnosis,” Lee added.
According to Boehringer, 18% to 32% of patients diagnosed with chronic ILDs are estimated to develop a progressive fibrosing disease course.
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