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Large clinical trial finds pirfenidone may help lung function in IPF patients
Date:5/17/2009

udies were very encouraging for IPF sufferers and added that "the safety and tolerability of pirfenidone was reassuring. The principal side effects experienced by patients in the studies were gastrointestinal discomfort and photo-sensitivity, both of which were manageable in the majority of patients."

The CAPACITY trials follow a Phase III clinical study conducted in Japan that was reported at the American Thoracic Society's 2008 International Conference in Toronto. That trial, which demonstrated the ability of pirfenidone to reduce the decline of lung capacity and improve progression-free survival, served as the basis for the Japanese regulatory authorities' approval of the medicine for the treatment of IPF in Japan.

Dr. du Bois concluded, "When taken in the context of the urgent unmet medical need for new medicines to treat IPF patients, the collective efficacy and safety data from the two CAPACITY studies, corroborated by a similar study in Japan, make a case for the use of pirfenidone in this disease setting."

InterMune, Inc., the developer of the medication, is preparing a New Drug Application (NDA) for pirfenidone for the treatment of IPF, which it expects to submit to the FDA in the summer of 2009, to be followed by a Marketing Authorization Application (MAA), which will be submitted to the European Medicines Agency (EMEA) around the end of 2009. Meanwhile, all patients in the study have been offered pirfenidone as part of an open-label, long-term safety study called RECAP.


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Contact: Keely Savoie
ksavoie@thoracic.org
212-315-8620
American Thoracic Society
Source:Eurekalert

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