Welcome to EmpowHER. I am so glad to hear that your father is having a positive response to treatment with Ofev (nintedanib).
For the benefit of all our readers, idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.
On October 15, 2014, the U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
The FDA granted Ofev fast track, priority review, orphan product, and breakthrough designations. Ofev is being approved ahead of the product’s prescription drug user fee goal date of Jan. 2, 2015, the date the agency was scheduled to complete the review of the drug application.
Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,231 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Ofev compared to patients receiving placebo.
Ofev is not recommended for patients who have moderate to severe liver problems. Ofev can cause birth defects or death to an unborn baby. Women should not become pregnant while taking Ofev. Women who are able to get pregnant should use adequate contraception during and for at least three months after the last dose of Ofev.
The most common side effects of Ofev are diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.
Ofev is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
Here is the link to the full report of "OFEV has been studied in 1231 patients with IPF across 3 clinical trials"
https://www.ofevhcp.com/efficacy/clinical-trials-design
Regarding cost, Boehringer Ingelheim pegged its brand-new treatment, Ofev, at $96,000.
For one, Boehringer has a patient support program in place, dubbed Open Doors, that features 24/7 access to nurse support, financial support resources and additional sources of information. On the access side, the pharma will offer up copay assistance of up to $30,000 per year, and for eligible patients without any financial resources, a patient assistance program will cover the entire cost.
Hope this was the information you were looking for.
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Hello Anonymous,
Welcome to EmpowHER. I am so glad to hear that your father is having a positive response to treatment with Ofev (nintedanib).
For the benefit of all our readers, idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.
On October 15, 2014, the U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
The FDA granted Ofev fast track, priority review, orphan product, and breakthrough designations. Ofev is being approved ahead of the product’s prescription drug user fee goal date of Jan. 2, 2015, the date the agency was scheduled to complete the review of the drug application.
Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,231 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Ofev compared to patients receiving placebo.
Ofev is not recommended for patients who have moderate to severe liver problems. Ofev can cause birth defects or death to an unborn baby. Women should not become pregnant while taking Ofev. Women who are able to get pregnant should use adequate contraception during and for at least three months after the last dose of Ofev.
The most common side effects of Ofev are diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.
Ofev is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
Here is the link to the full report of "OFEV has been studied in 1231 patients with IPF across 3 clinical trials"
https://www.ofevhcp.com/efficacy/clinical-trials-design
Regarding cost, Boehringer Ingelheim pegged its brand-new treatment, Ofev, at $96,000.
For one, Boehringer has a patient support program in place, dubbed Open Doors, that features 24/7 access to nurse support, financial support resources and additional sources of information. On the access side, the pharma will offer up copay assistance of up to $30,000 per year, and for eligible patients without any financial resources, a patient assistance program will cover the entire cost.
Hope this was the information you were looking for.
Maryann
January 12, 2016 - 11:00amThis Comment
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