Pirfenidone, the drug that is currently being studied at the NIH to treat the pulmonary fibrosis of Hermansky-Pudlak Syndrome, has been approved for IPF by the Japanese version of the FDA.
I can't help but think that this will only help us get it approved here. (For friends and family, the drug trial I'm in is for this drug.)
DGNews
Pirfenidone Approved in Japan for Treatment of Idiopathic Pulmonary Fibrosis
NEW YORK -- October 16, 2008 -- The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in Japan.
The approval is based on the results of 2 randomised, double-blind, placebo-controlled, phase 3 studies. The Clinical Studies Assessing Pirfenidone in IPF: Research of Efficacy and Safety Outcomes (CAPACITY) trials included 779 patients with IPF at 110 centres in the US, Europe, and Australia.
The primary endpoint in CAPACITY was change in Forced Vital Capacity (FVC) from baseline to week 72. InterMune states that 97% of transplant-free, surviving patients had completed the week 72 visit and primary endpoint was being assessed.
The CAPACITY protocol calls for a final patient visit to be completed 30 days after the week 72 visit. All patient visits for CAPACITY are expected to be completed around the end of October 2008. Based on this timeline for study completion, InterMune expects to announce efficacy and safety results in January or February of 2009.SOURCE: InterMune
I can't help but think that this will only help us get it approved here. (For friends and family, the drug trial I'm in is for this drug.)
DGNews
Pirfenidone Approved in Japan for Treatment of Idiopathic Pulmonary Fibrosis
NEW YORK -- October 16, 2008 -- The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in Japan.
The approval is based on the results of 2 randomised, double-blind, placebo-controlled, phase 3 studies. The Clinical Studies Assessing Pirfenidone in IPF: Research of Efficacy and Safety Outcomes (CAPACITY) trials included 779 patients with IPF at 110 centres in the US, Europe, and Australia.
The primary endpoint in CAPACITY was change in Forced Vital Capacity (FVC) from baseline to week 72. InterMune states that 97% of transplant-free, surviving patients had completed the week 72 visit and primary endpoint was being assessed.
The CAPACITY protocol calls for a final patient visit to be completed 30 days after the week 72 visit. All patient visits for CAPACITY are expected to be completed around the end of October 2008. Based on this timeline for study completion, InterMune expects to announce efficacy and safety results in January or February of 2009.SOURCE: InterMune
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