FIBROTIC DRUGS APPROVED BY FDA!!!!!

Huge news! The FDA approved both of the anti-fibrotic drugs to treat IPF that we have been writing about for a couple of years. After spending $100M in studies, pirfenidone is finally approved here in the US. The other drug, nintedanib, was already a drug but has just been approved to treat IPF. This is a very big deal.

To get further information, see the information below.

A big day for those of us with an ILD. Hopefully, one day soon these drugs will also be prescribed off label to those of us who have an ILD other than IPF.

A new day has come!  The FDA has approved not one, but two drugs for Idiopathic Pulmonary Fibrosis.  Yesterday, the FDA approved Boehringer Ingelheim's Ofev (nintedanib) and InterMune's Esbriet (pirfenidone).  Please see links to the press releases the Coalition for Pulmonary Fibrosis sent out in response to the news below.  Also, there is important information pasted below that we are forwarding from the FDA.  There will be a conference call tomorrow (Friday, Oct. 17) for all stakeholders including patients, caregivers, family members, advocates, researchers, clinicians and others. See below for information on how to join the call. Sincerely,  Mishka Michon, CEO, Coalition for Pulmonary Fibrosis Click the headlines to view full content: Two FDA Approvals on Same Day Renew Hope for Pulmonary Fibrosis Community: IPF Patient and Actress Barbara Barrie, Others Respond to News CPF Responds to FDA’s Approval of First Drug for Idiopathic Pulmonary Fibrosis Information from FDA on Conference call on Friday: The FDA approved two new products for the treatment of idiopathic pulmonary fibrosis: Esbriet (pirfenidone) and Ofev (nintedanib).  Both products were granted FDA fast track, priority review, orphan product, and breakthrough designations.  They were also both approved ahead of their respective prescription drug user fee goal dates.  Technical experts within the Center for Drug Evaluation and Research would like to communicate with clinicians and other stakeholders about the use of Esbriet and Ofev, including a discussion of clinical and safety considerations.  You and your colleagues are invited to participate in a stakeholder call this Friday, October 17th at 2pm EST.  More information: Stakeholder Call- Live US Dial-in: 888-469-1066; passcode FDA International Dial-in: 1-312-470-7282; passcode FDA Stakeholder Call- Replay Available one hour after the call ends until November 17th US Dial-in: 888-325-4186; passcode 45997 International Dial-in: 1-402-998-1251; passcode 45997       Coalition for Pulmonary Fibrosis 10866 W. Washington Blvd. #343 Culver City, CA 90232 (888) 222-8541 info@coalitionforpf.org