We have been following pharmaceuti- cal company InterMune and its battle to get pirfenidone approved in the United States. The drug has been available to treat idiopathic pulmonary fibrosis (IPF) in Europe, Canada, Japan, South Korea, China, India, Argentina and Mexico where it is known as Esbriet. In a surprise move in May 2010, the U.S. Food and Drug Administration (FDA) denied approval of pirfenidone, citing the lack of data to prove its effectiveness in treating IPF and asked for further clinical trials.
The results of the Phase 3 ASCEND trial showed that after a year of treatment, 16.5 percent of patients in the pirfenidone group experienced disease progression, around half the level of those using a placebo. The study also showed that 22.7 percent of patients getting the drug experienced no decline in lung function, more than double the 9.7 percent seen among those taking the placebo. Pirfenidone had a favorable safety profile and was generally well tolerated. InterMune will now resubmit its application for approval of the drug to the FDA before the end of the year.
Another pharmaceutical company, Boeh- ringer Ingelheim, is also developing a drug, Nintedanib (BIBF 1120), for treating IPF and the company is expected to present data from a late-stage trial of the drug sometime this year. If the FDA approves the drug, never a given, the earliest Americans will be able to benefit is mid-2015.
Teresa Barnes, VP, Patient Out- reach & Program fSourptphoert Co- alition for Pulmo- nary Fibrosis, tells us the organization’s Daughters of PF program launched a campaign called A Daughter’s Love.
Senator Mark Kirk from Illinois
(who lost his father to PF)
while she was in Washington raising
aware ness of Pulmonary Fibrosis.
Women all over the world are joining in by posting a photo of their loved one on social media inside a heart and telling their stories about why they are a member of Daughters of PF and how they want to increase awareness of the disease. The group has hundreds of women, most of whom have lost a parent to PF, but a growing number are joining who are wives, sisters, moms and other family members of patients past or present. Any woman whose life has been affected by Pulmonary Fibrosis is invited to join this group by visiting www.coali- tionforpf.org or calling 1-888-222-8541, Extension 702. The Daughters also have a Facebook page.
Below is the Daughter’s Love heart Teresa made in tribute to her father, Hollis Richard- son, who succumbed to Pulmonary Fibrosis.