FDA Approves Two New Drugs for Treating Pulmonary Fibrosis

Pulmonary fibrosis is an inflammatory disease in which patients have difficulty breathing, as it is challenging for the lungs to expand sufficiently. This is a deadly disease that had no drug-based therapy until recently. The FDA Voice Blog reports that that the U.S. Food and Drug Administration approved Ofev (nintedanib) and Esbriet (pirfenidone), two new drugs for treating idiopathic pulmonary fibrosis (IPF), a terminal type of the condition.

While the medications do not cure the disease, they do seem to play a role in stopping the signaling pathways that lead to scarring of lung tissue. These two drugs really offer new opportunities for patients with IPF, as they have been shown to significantly inhibit the progression of the disease.

In an attempt to push forward drug development for IPF, the FDA held a Public Meeting on Idiopathic Pulmonary Fibrosis Patient-Focused Drug Development. At this conference, patients were asked to describe how IPF affects their daily life and how they view current treatments for the disease. Due to the recent approval of Ofev and Esbriet, patients with IPF will now have effective treatment and the FDA continues to work toward improving drug therapies for those with serious medical conditions.

A press release from the FDA explains that idiopathic pulmonary fibrosis leads to coughing, shortness of breath, and inability to take part in common everyday activities. Common therapies for IPF have been pulmonary rehabilitation, oxygen therapy, and even lung transplants.

“Today’s Ofev approval expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic condition,” Dr. Mary Parks, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need.”

Ofev was a fast-track orphan drug and was actually approved before the scheduled, goal date of January 2, 2015. Both the FDA and the researchers behind it were pushing forward with this medication in order to bring a more effective treatment for those with idiopathic pulmonary fibrosis.

Both Ofev and Esbriet were initially tested in preclinical mouse studies along with more rigorous clinical analysis. Ofev was tested in three clinical trials in which more than 1,200 patients were enrolled. This drug is a kinase inhibitor and inhibits several pathways that may lead to lung tissue scarring.

Esbriet was also on a fast-track to approval and was given the green light before its designated date of November 23, 2014. This drug’s safety was determined through several clinical trials following about 1,250 IPF patients. This medicine does have some side effects such as abdominal pain, nausea, fatigue, upper respiratory tract infection, headaches, dizziness, vomiting, insomnia, and weight loss.

Those with pulmonary fibrosis have a much better chance at living longer and having a better quality of life due to these two new medications. With the help of both preclinical and clinical studies, investigators were able to develop these effective drugs.

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Categories: Inflammatory diseases

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