FDA approval of Roche, Boehringer drugs for idiopathic pulmonary fibrosis is a big step forward
The U.S. Food and Drug Administration (FDA) has approved two drugs for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic lung disease.
IPF usually occurs in people over the age of 50 years, particularly those who have a history of cigarette smoking. However, the cause of IPF is still unclear but patients find it difficult to breathe and their lungs are scarred. Patients usually survive for about two to five years post diagnosis and lung transplant is currently supposed to be the only treatment for IPF. The disease normally affects more men than women.
In the U.S., IPF affects more than 120,000 Americans and about 48,000 patients are treated with the disease each year.
Till now there has been no drug treatment for the disease approved by the FDA. However, on Wednesday, Oct. 15, the federal agency has approved two drugs called Esbriet made by Swiss company Roche and Ofev manufactured by German pharmaceutical firm Boehringer Ingelheim for the treatment of IPF. Both the drugs do not cure IPF but they slow down the decline rate of the lungs. The FDA suggests that both the drugs have shown their ability to significantly reduce the advancement of IPF in patients.
"Many patients in the U.S. with IPF will now have effective treatments for their condition. We are addressing the input received from our public meeting on IPF and will continue to support the development and approval of new drugs, especially those that help patients with serious or life-threatening conditions for which no drug treatments are available," per a FDA blog.
Daniel M. Rose, the chief executive of the Pulmonary Fibrosis Foundation, revealed that it is exciting as IPF patients in the U.S. have now support from two new approved therapies. He says that the news of the approval of drugs has also given a light of hope to patients suffering from the deadly disease.
However, Rose is concerned if insurers will agree to pay for the drugs as they will have a steep price tag when compared to Canada and Europe. Esbriet would cost around $7,800 per month, which equated to $94,000 a year. Boehringer representatives did not reveal Ofev's price and suggested it will be disclosed once the drug is made available, probably in the next 10 days.
A Roche's spokesperson revealed that the price of Esbriet is based on how well the drug works to treat IPF.
FDA suggests that there is still a lot of work to be done for the treatment of IPF and the approval of these two drugs is just the starting.