Esbriet, also known by the generic name of pirfenidone, is an anti-fibrotic drug that is available commercially in the U.S., the United Kingdom, and Asia. It is used to treat mild to moderate cases of idiopathic pulmonary fibrosis (IPF).
History of Esbriet
Esbriet is one of two landmark IPF therapies approved by the U.S. Food and Drug Administration (FDA) in 2014, along with Ofev (nintedanib). Japan was the first country to approve its commercial use in 2008, followed by India in 2010, Europe in 2011, and China in 2013. Because IPF is considered a rare condition, the drug was granted orphan drug status in 2004.
How Esbriet works
The word “idiopathic” means the cause of IPF remains a mystery. Regardless of the causes, there is an aggregation of scar tissue in the lungs likely due to a range of inflammatory reactions in response to primary infections or excess secretion of collagen by fibroblasts and cells. The decrease in oxygen diffusion capacity causes stiffness in the lungs, which can cause discomfort.
Esbriet is an anti-inflammatory and anti-fibrotic drug that reduces inflammation and fibrosis simultaneously. The main mode of action lies in reducing fibroblast secretion and inhibiting TGF-β (which is responsible for excess collagen production), and reducing the secretion of inflammatory mediators like TNF-α and IL-1β. Both pre-clinical and human studies have shown the effectiveness and safety of the drug in terms of tolerance and side effects.
A considerable improvement in the levels of forced expiratory volume (FEV), normalized secretion of pro-inflammatory cytokines, and reduction in the fibrotic lung tissues were some of the highlights of several clinical trials undertaken on a dose-dependent basis. Researchers observed that progression-free survival (a measure of the treatment potential of the drug on the disease) was also increased significantly in these trials.
Other facts about Esbriet
Esbriet is administered orally and is recommended to be taken after food (usually three times daily) to reduce nausea and dizziness in patients. It is mostly metabolized in the liver and excreted in the urine within 24 hours. Mild side effects include nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, indigestion, dizziness, vomiting, decreased or loss of appetite, gastro-esophageal reflux disease (GERD), sinusitis, insomnia, weight loss, and arthralgia.
Post-marketing experience reactions are voluntarily reported from a population of uncertain size, making it difficult to establish a relationship with drug exposure. Many of the adverse reactions reported during post-approval of Esbriet in Japan are consistent with clinical trials and include abdominal discomfort, constipation, diarrhea, gastric disorders, increased blood liver markers, decreased appetite and distortion of the sense of taste, dizziness, somnolence, photosensitivity reaction, itching, and rash.
Patients with severe liver problems, end-stage kidney disease, those who require dialysis, or who are taking fluvoxamine (a medication used to treat depression and obsessive compulsive disorder) are not advised to take Esbriet. Pregnant women need to consult with their doctors before taking the drug.
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