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It affects as many as 132,000 Americans, typically men over the age of 65. Food and Drug Administration (FDA) approved Ofev for the treatment of idiopathic pulmonary fibrosis (IPF) on .
Early diagnosis and proper care are critical to helping people treat their condition. Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.
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Our vision is to change progressive fibrosing lung diseases, such as IPF, from fatal diseases to chronic, treatable conditions, and our research continues to evolve treatment knowledge to help transform care for patients.
As part of our commitment, Boehringer Ingelheim is currently enrolling patients to participate in two further clinical trials exploring the full extent of the potential benefit of nintedanib in a broader range of progressive fibrosing lung conditions, other than IPF - SENSCIS™ and PF-ILD.
However, further research will be necessary to fully evaluate the efficacy of the combination.
"These new results suggest a potential benefit of the combination treatment of nintedanib with add-on pirfenidone in people with IPF, but that will need to be further evaluated," said , Ph.
The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW™ trial and the Phase III INPULSIS trials were identically designed while the TOMORROW™ study design was similar. Ofev is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
It is not known if Ofev is safe and effective in children.
The SENSCIS study (Safety and Efficacy of Nintedanib in Systemic SCleros IS) is the largest trial to date treating patients with systemic sclerosis (also known as scleroderma) who have also developed interstitial lung disease (SSc-ILD).
The PF-ILD (progressive fibrosing interstitial lung disease) trial builds on the positive real-world clinical experience in IPF to determine whether nintedanib can effectively treat patients suffering from other progressive fibrosing-ILDs.
Nintedanib is one of two antifibrotic drugs which have been shown to slow the progression of the disease in patients with IPF.
INJOURNEY was a 12-week, open-label, randomized trial evaluating the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone compared with nintedanib alone, in patients with IPF.
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