PF Patients Plead with FDA Advisory Panel to Hear Their Voices, Understand Their Plight
The Coalition for Pulmonary Fibrosis (CPF) and the Pulmonary Fibrosis Foundation (PFF) are applauding the efforts of Pulmonary Fibrosis (PF) patients and family members for their work to convey to the FDA and an FDA Advisory Committee the sense of urgency and desperation regarding the disease and the lack of treatment options. Their words were heard yesterday by the 11-member Advisory Committee and representatives of the FDA during a public hearing portion of the FDA Pulmonary-Allergy Drugs Advisory Committee discussion of a potential new therapy in the fight against PF. The committee voted 9 to 3 to recommend approval for the drug by the FDA.
If approved, the therapy, Pirfenidone, would be the first FDA approved drug for PF. PF is a progressive, relentless and irreversible scarring of the lungs which renders patients unable to breathe and is almost invariably fatal within two to five years.
"There's no question that the patient perspective was heard by the FDA and the panel," said Mishka Michon, Chief Executive Officer of the Coalition for Pulmonary Fibrosis. "Family members and patients spoke from their hearts and conveyed the sense of urgency they feel in desperately waiting for a treatment for this horrific disease."
"We are humbled by the courage and determination of our patients," said Daniel Rose, M.D., President of the Pulmonary Fibrosis Foundation. "The voice of the patient community is a critical component in finding solutions to PF."
The panel listened to testimony of 15 PF patients and family members for an hour. It also received a stack of letters from patients and families from across the country who could not attend the meeting in person.
Advocate Joy McBride opened the public hearing portion of the meeting by sharing with the panel the loss of her father and uncle to PF. "The hardest part was hearing from the doctors 'there is nothing I can do for you,'" she said. "Today, there is still no known cause, no cure, and no hope."