RIDGEFIELD, Conn., October 20, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. has announced that OFEV® (nintedanib) capsules are now commercially available in the United States.
OFEV was approved by the U.S. Food and Drug Administration (FDA) on October 15, 2014 for the treatment of idiopathic pulmonary fibrosis (IPF). It is the only kinase inhibitor approved to treat IPF.
IPF is a rare and fatal lung disease that affects as many as 132,000 Americans. Most people with IPF only live three to five years after diagnosis. IPF typically affects men over the age of 65.
To support the launch of OFEV, Boehringer Ingelheim has established OPEN DOORS™, a comprehensive patient support program that provides a broad range of financial and nursing support services. One of the goals of this program is to help patients who are prescribed OFEV gain rapid and affordable access to the medicine.
“We are proud to be able to offer IPF patients an effective therapy for this rare and fatal disease, together with comprehensive programs and services to support patients and healthcare providers as they begin therapy with OFEV,” said Tunde Otulana, M.D., a pulmonologist and senior vice president, Clinical Development and Medical Affairs at Boehringer Ingelheim. “Bringing a new treatment such as OFEV to patients when there is such significant unmet need is the result of many years of research and demonstrates our commitment to making a difference for patients with respiratory diseases.”
OPEN DOORS™ services and resources include:
Access to support from specially-trained nurses – 24 hours a day, 7 days a week
Assistance in finding financial resources to support access to OFEV
Access to information about IPF and assistance in identifying local resources, such as support groups
OFEV is commercially available through specialty pharmacy distributors, as well as a select network of pharmacies. The dedicated specialty pharmacy model is intended to provide one point of contact for efficient, reliable service, and consistent product supply. Pharmacies offering OFEV were selected for their experience caring for patients with severe respiratory diseases. Selected pharmacies are uniquely positioned to offer additional services including respiratory therapy and oxygen.
About OFEV (nintedanib) capsules
Indication and Usage
OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
IMPORTANT SAFETY INFORMATION
Elevated Liver Enzymes
The safety and efficacy of OFEV has not been studied in patients with moderate (Child Pugh B) or severe(Child Pugh C) hepatic impairment. Treatment with OFEV is not recommended in patients with moderate or severe hepatic impairment.
In clinical trials, administration of OFEV was associated with elevations of liver enzymes (ALT, AST, ALKP, GGT) and bilirubin. Liver enzyme increases were reversible with dose modification or interruption and not associated with clinical signs or symptoms of liver injury.
Conduct liver function tests (ALT, AST, and bilirubin) prior to treatment with OFEV, monthly for 3 months, and every 3 months thereafter, and as clinically indicated. Dosage modifications, interruption, or discontinuation may be necessary for liver enzyme elevations.
Gastrointestinal Disorders
Diarrhea
Diarrhea was the most frequent gastrointestinal event reported in 62% versus 18% of patients treated with OFEV and placebo, respectively. In most patients, the event was of mild to moderate intensity and occurred within the first 3 months of treatment. Diarrhea led to permanent dose reduction in 11% of patients treated with OFEV compared to 0 placebo-treated patients. Diarrhea led to discontinuation of OFEV in 5% of the patients compared to <1% of placebo-treated patients.Read More
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