FDA approves first new drug to treat patients with rare lung disease

The U.S. Food and Drug Administration today approved Ofev capsules to slow the decline in lung function in patients with interstitiotic pulmonary disease associated with systemic sclerosis or sclerosis, known as SSc-ILD. This is the first FDA-approved treatment for this rare lung disease.
“ Patients with styluses need effective treatment, and the U.S. Food and Drug Administration supports drug companies in designing and conducting the necessary clinical trials to provide treatment options for patients with stylus disease," said Dr. Nikolai Nikolov, deputy director of rheumatology at the U.S. Food and Drug Administration's Center for Drug Evaluation and Research." S
is a rare disease that thickens and scars throughout the body, including the lungs and other organs. Interstital pulmonary disease or ILD is a disease that affects interstital disease, which is part of the lung structure and is one of the most common manifestations of stethosis. SSc-ILD is an aggressive lung disease in which lung function declines over time and can be debilitating and life-threatening. ILD is the leading cause of death in patients with squalosis, usually due to loss of lung function due to the inability of the lungs to provide enough oxygen to the heart. About 100,000 people in the United States suffer from stylus disease, and about half of people with stethosis suffer from interstity lung disease.
The effectiveness of Ofev's treatment of SSc-ILD was studied in a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79. Patients received 52 weeks of treatment, and some received up to 100 weeks of treatment. The main test of efficacy is to measure lung capacity, or FVC, which is a measure of lung function and is defined as the amount of air forced out of the lungs after breathing as deep as possible. Compared to the placebo group, the lung function of the Ofev group decreased less.
The overall safety observed by the researchers in the Ofev treatment group was consistent with the known safety of the treatment. The most common serious adverse event reported in patients treated with Ofev was pneumonia (2.8% Ofev: 0.3% placebo). It was reported that 34 per cent of Ofev patients had adverse reactions that resulted in a permanent dose reduction, while 4 per cent of patients treated with a placebo were treated. Diarrhea is the most common adverse reaction that causes a permanent dose reduction in Ofev patients.
Ofev's prescription information includes warnings for patients with moderate or severe liver (liver) damage, patients with elevated liver enzymes and drug-related liver damage, and patients with gastrointestinal disorders. Ofev can also cause embryo-fetal toxicity, which can lead to fetal injury, arterial thromboembolism events (thrombosis), bleeding and gastrointestinal perforation. P-gp and CYP3A4 inhibitors may increase nitedanib exposure and the tolerance to Ofev in patients taking these inhibitors should be closely monitored. Note that common side effects of Ofev include diarrhea, nausea, abdominal pain, vomiting, elevated liver enzymes, loss of appetite, headache, weight loss, and high blood pressure (hypertension).
Ofev was originally approved in 2014 for adult patients with idynogenic pulmonary fibrosis (IPF), another interstital lung disease.
Ofev was given a priority review designation under which the FDA aims to take action on the application within six months, and the agency determined that if approved, the drug would significantly improve the safety or effectiveness of treating, diagnosing or preventing serious illnesses. Ofev has also been awarded the title of Orphan Drug and has provided incentives to assist and encourage drug development for rare diseases.FDA approves New Drug Ofev for the treatment of interstitiotic pulmonary disease at Bronger Ingeham Pharmaceuticals. （cyy123.com）