Yesterday the FDA issued a statement about Pirfenidone. Below is a message from Donna. We've posted it to the listservs, but I know everyone isn't on the listservs so thought I'd share it here too.
Yesterday we got the news that the FDA would like InterMune (the Pharmaceutical Company that owns Pirfenidone) to conduct another clinical trial using Pirfenidone and they did not approve the drug for market at this time. We were hoping that today would be the day that Pirfenidone would become available. It was not to be, just yet. Heather and I listened to a 40 minutes Conference Call that was given by InterMune yesterday afternoon. They spoke about the decision the FDA made to ask for another trial and the company did not know much more than that until they meet with the FDA so that they can understand what they are looking for.
Although we are really disappointed, we do not think InterMune will stop their work. We will have to continue to be ready for any opportunity that may come our way. So please use these setbacks to fuel our passion to find everyone there is in the world with HPS. Someday, our dreams will come true. We will have a treatment. Until then we have work to do.