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12:00 AM
Oct 13, 2014
 |  BioCentury  |  Regulation

The lung haul

IPF patients want drugs that stop or reverse progression, help with symptoms

Patients at FDA's recent workshop on idiopathic pulmonary fibrosis said they want treatments that can halt or reverse the progression of fibrosis and - just as importantly - improve quality of life. But they will have a long wait, as the two IPF treatments under FDA review can help slow disease progression but have limited effects on symptoms.

Products in the clinic that might stop progression or alleviate symptoms are at least four years away from market. IPF patients typically live only three to five years after diagnosis.

IPF is characterized by progressive scarring of the lungs that impedes their ability to expand and provide oxygen to the bloodstream. Over time, patients lose lung capacity and suffer from dyspnea, cough, fatigue and changes in the shape of their fingers and toes due to the lack of oxygen.

Patients and caregivers at last month's patient-focused drug development meeting said the symptoms with the most impact on daily life were shortness of breath (93%), cough (73%), fatigue (57%) and depression (23%).

Faye MacInnis said before her husband Phil died of IPF in 2013, it took him an hour and a half to get dressed each morning.

"It took him so long to walk to the closet to get the clothes, then he had to sit down, then he'd have to rest after each article he put on," she said.

Coughing episodes are both debilitating and socially embarrassing, and keep some patients from holding a normal conversation.

"You may wake up in the morning and cough so hard that you actually throw up in your mouth. I'm sorry to say that, but it's the truth. And it literally wipes you out - physically, you are exhausted," said Diane Reichert, a patient ambassador for the Pulmonary Fibrosis Foundation.

Reichert said her symptoms include shortness of breath, fatigue and pain in her extremities.

FDA has not approved any treatments for IPF. Without a lung transplant - the only cure - patients manage their symptoms with pulmonary rehabilitation...

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