Ofev (nintedanib) capsules, a new drug treatment for idiopathic pulmonary fibrosis (IPF) developed by Boehringer Ingelheim Pharmaceuticals, Inc. is already being made available in select pharmacies throughout the United States with a prescription. The announcement of Ofev’s availability was recently made by the company, and follows the drug’s approval by U.S. Food and Drug Administration (FDA), which was announced on October 15th.
The drug therapy is the only kinase inhibitor approved to treat IPF, and together with Esbriet (pirfenidone) from InterMune, Inc./Roche Holding AG, which was approved by the FDA on the same day, is one of the two only medications in the country specifically designed for the treatment of the disease, which affects about 132,000 Americans and leads to death on an average of five years after diagnosis.
“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 the senior vice president of Clinical Development and Medical Affairs at Boehringer Ingelheim and pulmonologist, Tunde Otulana, M.D. “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.”
In addition to the launch of the medication, the company also initiated a comprehensive patient support program called Open Doors to provide financial and nursing assistance for IPF patients. In order to help patients get fast, affordable access to the treatment, the services offered by the program include access to support from specially-trained nurses 24 hours a day, 7 days a week, assistance in finding financial resources to support the use of the drug, as well as access to information about the disease, local resources, and support groups.
The announcement of the support program is particularly relevant to IPF patients, since Boehringer recently made headlines with the news that Ofev would cost $96,000 per year. Esbriet, its competitor, on the other hand, won’t cost much less, and while the price tag for Esbriet has yet to be confirmed by InterMune, Inc./Roche Holding AG, it has been reported by analysts to be $94,000 a year.
Ofev is already being sold at specialty pharmacy distributors, in addition to a selected network of pharmacies. The German company plans to provide a point of contact for efficient, reliable service and consistent product supply by adopting the dedicated specialty pharmacy model. The facilities that are offering the drug were chosen based on experience in patient care, being specially focused on severe respiratory diseases, and being able to provide additional services like respiratory therapy and oxygen.
In addition, Boheringer has also launched a mobile app and web page self-test, as a way of raising awareness about the disease. “IPF Sound Challenge” is an app in which users have to identify several respiratory conditions, including IPF, and the self-test Web page is designed for patients to determine if the “Velcro crackles” detected are serious enough to indicate or if there is still needed more investigation.
InterMune also announced the launch of Esbriet recently, which will also be available with a prescription. The Pulmonary Fibrosis Foundation applauded the FDA decision of approving both of the treatments for IPF, and the foundation’s Chief Medical Officer Gregory P. Cosgrove called it a “landmark” for the research and treatment of the disease.