Ofev: A Ray of Hope for PF-ILD Patients
2 June, 2022 | DelveInsight
- Ofev became the first approved drug to enter the market for chronic fibrosing ILDs with a progressive phenotype.
- Data from the clinical study shows that Ofev reduces the rate of decline in FVC in patients aged <75 years as well as ≥75 years, with a greater treatment effect in patients aged ≥75 years
A proportion of interstitial lung disease (ILD) patients develop a progressive phenotype known as Progressive-Fibrosing Interstitial Lung Disease (PF-ILD). According to the DelveInsight assessments, there were approximately 234,200 prevalent cases of PF-ILD in 2021 in the 7MM (the US, EU-5 countries (Germany, France, Italy, Spain, and the UK), and Japan).
The treatment options for PF-ILD have historically been limited (corticosteroids, immunosuppressants, and certain off-labeled drugs already approved for other subtypes of ILD) due to disease complexity and its progression. Elderly patients with ILDs are more likely to be frail and to have comorbidities that complicate their care.
Nintedanib (Ofev, Boehringer Ingelheim GmbH) is an oral intracellular tyrosine kinase inhibitor that targets multiple tyrosine kinases resulting in disruptions in the signaling pathway for fibroblast proliferation and activation. Recently, under Priority Review and Breakthrough Therapy status, nintedanib became the first approved treatment for patients with PF-ILD. The approval was based on the Phase III INBUILD trial, in which Ofev slowed lung function decline by 57% relative to placebo across the overall study population as assessed by the annual rate of decline in forced vital capacity (FVC).
At the recently held American Thoracic Society 2022 International Conference, Boehringer Ingelheim International GmbH presented new data from the INBUILD trial on the efficacy and safety of nintedanib in elderly patients with PF-ILD. Of the total patients, 19.0% were aged ≥75 years at baseline and the rest aged ≥75 years. Nintedanib was found to reduce the rate of decline in FVC in both subgroups by age, with a greater treatment effect in patients aged ≥75 than <75 years. Adverse events leading to treatment discontinuation were more frequent in patients aged ≥75 than <75 years. In the nintedanib group, the patients with adverse events leading to treatment discontinuation were 18.9% in patients aged <75 years and 36.8% in those aged ≥75 years, and the proportions of patients with serious adverse events were 42.9% in those aged <75 years and 50.9% in those aged ≥75 years.
Building on the results of the INBUILD trial, there are multiple clinical trials addressing nintedanib use in patients with PF-ILD that are currently active, results of which will help to guide the utilization of nintedanib in patients with PF-ILD moving forward.
Management decisions for patients with PF-ILD have historically been challenging due to the paucity of validated therapeutic interventions. The approval of nintedanib has brought new hope to PF-ILD treatment. Also, as only a few pharmaceutical companies are focusing on the search for PF-ILDs treatment and there are not many ongoing clinical trials for the indication, the drug is expected to be the market leader in the PF-ILD market, continuing to be one of the best-selling drugs of the company. It’s already approved in more than 60 countries for PF-ILD. This is a good opportunity for other big pharmaceutical companies to enter the market by making strategic decisions to compete with the already approved candidate Nintedanib by Boehringer Ingelheim for the treatment of patients affected with PF-ILD.
For a more detailed analysis of the PF-ILD market visit: Progressive Fibrosing Interstitial Lung Disease Market