CPF Calls on Manufacturer and FDA to Expedite Review of Pirfenidone as Treatment for PF

The Coalition for Pulmonary Fibrosis (CPF) is calling a historic day in the research and treatment of PF, as InterMune has announced positive results from its pivotal Phase III clinical trial of Pirfenidone, which could pave the way for the first FDA-approved therapy to treat PF – a relentlessly progressive and ultimately fatal lung disease affecting more than 128,000 people and claiming 40,000 lives each year. The CPF urges the FDA to review InterMune’s new drug application (NDA) as soon as possible, given that there are no current FDA-approved treatments for PF.

“For patients living with a lethal and ultimately fatal disease, these data indicate that Pirfenidone may allow them breathe better, walk further, and live longer,” said CPF Founder and Chief Operating Officer Mark Shreve. “If approved, Pirfenidone would represent a historic and desperately needed advance in the treatment of PF.”

The CPF has long advocated on behalf of researchers and patients for accelerated research efforts to treat and cure PF, both in terms of drug development efforts by the pharmaceutical industry and research funded by the National Institutes of Health (NIH). “We need industry to do more and we need the government to do more in PF,” said Shreve.

“While this study does not represent a cure, it IS a historic first step in treating PF, and is a shining ray of hope for the thousands of patients suffering from this terrible disease,” said Mishka Michon, Chief Executive Officer of the CPF.

“Unfortunately due to the regulatory process, another 40,000 patients will die this year from PF while the NDA is submitted and reviewed by the FDA. We call on the FDA and the manufacturer to make every possible effort to review and approve this therapy, so that lives may be saved,” Shreve said.

Source: Coalition for Pulmonary Fibrosis




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