FDA green lights Ofev to treat idiopathic pulmonary fibrosis

FDA green lights Ofev to treat idiopathic pulmonary fibrosis

Pulmonary fibrosis is serious a disease that involves the thickening and stiffening of the tissue deep in the lungs over time.

The FDA has approved a new drug, Ofev, for treating patients with idiopathic pulmonary fibrosis.

Pulmonary fibrosis is serious a disease that involves the thickening and stiffening of the tissue deep in the lungs over time. The formation of scar tissue is called fibrosis, which causes the lungs to be unable to properly move oxygen into the bloodstream. Idiopathic pulmonary fibrosis (IPF) refers to cases where the causes cannot be found.

Symptoms of IPF include shortness of breath, cough, and difficulty carrying out everyday physical activities.

Mary H. Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, is encouraged by Ofev as an alternative to more invasive treatments for IPF, including oxygen therapy, pulmonary rehabilitation, and lung transplant.

“Today’s Ofev approval expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic condition. Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need,” said Parks in a statement.

Ofev is a kinase inhibitor which blocks pathways that are involved in lung tissue scarring. Three clinical trials were conducted to test the effectiveness of Ofev, which included 1,231 patients with IPF. The patients who took Ofev experienced a significant reduction in forced vital capacity – which is the amount of air that can be exhaled from the lungs following a deep breath – compared to those who received a placebo.

Common side effects of Ofev include abdominal pain, vomiting, diarrhea, nausea, reduced appetite, weight loss, high blood pressure, headache and liver enzyme elevation.

Ofev is not recommended for people with moderate to severe liver conditions, or women who are pregnant or plan to become pregnant.

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