The U.S. FDA Panel gave a green signal to Ofev, a kinase inhibitor, to treat idiopathic pulmonary fibrosis.
In a latest announcement, the U.S. Food and Drug Administration revealed that it has approved Ofev (nintedanib) to treat idiopathic pulmonary fibrosis (IPF), a condition in which the lungs get progressively scarred over time.
This serious and chronic disease is known to affect middle-aged and older adults and the seriousness varies from person to person. Idiopathic means that the cause remains a mystery. This disease makes the tissue deep in the lungs thick and stiff due to which the lungs fail to provide oxygen into the bloodstream. Due to this condition, the brain and other organs do not receive sufficient oxygen.
Those with IPF experience shortness of breath, cough and have difficulty participating in everyday physical activities. The current treatment for IPF include 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," said Mary H. Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient's need."
The Ofev fast track received the priority review, orphan product and breakthrough designation from the FDA. It has been approved ahead of the product prescription drug user fee goal date of January 2, 2015 - the date the agency is expected to complete the review of the drug application.
The newly approved Ofev is a kinase inhibitor that blocks several pathways that may be involved in the scarring of the lung tissue. The safety and effectiveness of this was tested in three different clinical trials that included 1,231 patients with IPF.
They observed that there was a significant drop in the forced vital capacity among those receiving Ofev as compared to those using a placebo. Forced vital capacity is the amount of the air which can be forcibly exhaled from the lungs after taking the deepest breath.
The FDA cautions that the drug is not approved for those who have moderate-severe liver problems. Ofev is also known to cause birth defects or death of unborn babies, hence pregnant women should refrain from taking Ofev. Those women who get pregnant should take adequate contraception during and for atleast three months after the last dose of Ofev.
The most common side effects reported were nausea, diarrhea, abdominal pain, vomiting, liver enzyme elevation, lower appetite, headache, reduced weight and hypertension.
Along with this, the FDA also gave approval to Esbriet to treat IPF. Ofev is being distributed by Boehringer Ingelheim Pharmaceuticals.