Wednesday, October 15, 2014

UPDATED: The FDA approve pirfenidone and nintedanib to treat IPF

The U.S. FDA approved both pirfenidone and nintedanib to treat IPF on October 14, 2014. This is wonderful news, since as you probably know, we've had nothing available to treat IPF in the United States other than oxygen, exercise, and lung transplantation. Both drugs should become available in the US by the end of October, and both pharmaceutical companies are offering financial assistance programs.

Don't forget that you can always call or email the Patient Communication Center at the Pulmonary Fibrosis Foundation at 844.Talk.PFF or pcc@pulmonaryfibrosis.org

You can read more about these medications on the following websites:


Pulmonary Fibrosis Foundation's announcement:
http://www.pulmonaryfibrosis.org/our-role/news-media/viewannouncement/pff-applauds-the-fda-for-prompt-decision-to-approve-esbriet-and-ofev-for-ipf

My blog post about these drugs:
http://www.pfdoc.org/2014/05/clinical-trial-results-for-pirfenidone.html 

Dr. Swigris' blog post about these drugs:
http://pulmonaryfibrosisresearch.org/ats-2014-debrief-explanation-of-results-from-four-ipf-drug-trials

A Pulmonary Fibrosis Foundation webinar about these drugs
http://pulmonaryfibrosis.org/life-with-pf/pff-educational-resources/webinars/ask-a-doc-clinical-trial-update

Pirfenidone (Esbriet®)

The FDA's announcement of pirfenidone approval (Brand name Esbriet®)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418991.htm

Patient information on Esbriet® from the FDA:
https://www.esbriet.com/doc/Esbriet_Patient_Information.pdf

Esbriet's® website including information about financial assistance through CareConnect:
https://www.esbriet.com/careconnect/patients/

Nintedanib (Ofev®)

The FDA's announcement of nintedanib approval (brand name Ofev®)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm 

Full prescribing information about Ofev (with patient information at the end):
http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Ofev/ofev.pdf 

Information from Boehringer-Ingelheim about the availability of Ofev (source):
"To support people living with IPF who will be prescribed OFEV, Boehringer Ingelheim has developed OPEN DOORS™ – a comprehensive patient support program that will provide a broad range of financial and nursing support services. Accessible through www.OFEV.com and at 1-866-673-6366, OPEN DOORS™ services and resources include:

  • Access to nurse support 24 hours a day, 7 days a week
  • Assistance in finding financial resources to support access to OFEV
  • Access to information about IPF and assistance in identifying local resources, such as support groups"

6 comments :

  1. So now people are going ok, which one? Just a reminder that David did a post of the ATS 2014 presented results as did Dr Jeff Swigris on his blog. In addition, PFF did an online webinar. Here are the links:

    http://www.pfdoc.org/2014/05/clinical-trial-results-for-pirfenidone.html

    http://nationaljewish.org/Participation-Program-for-Pulmonary-Fibrosis/Comm unity/Blog/Participation-Program-for-Pulmonary-Fibrosis/June-2014/ATS-2014- DEBRIEF-explanation-of-results-from-four-IPF-drug-trials

    http://pulmonaryfibrosis.org/life-with-pf/pff-educational-resources/webinar s/ask-a-doc-clinical-trial-update

    ReplyDelete
  2. For information re Esbriet (pirfenidone), visit www.esbriet.com/careconnect:

    Get started on Esbriet therapy with Esbriet CareConnect™

    Once you and your doctor have decided that Esbriet is appropriate for you, Esbriet CareConnect will help you get started on your treatment by providing one-on-one, personalized support through a nurse case manager.

    ReplyDelete
  3. My 79 year old retired military officer father has recently been diagnosed with IPF. He has always been extraordinarily dedicated to fitness and proper diet.They are hesitant to put him either of the two new IPFmeds fearing abdominal/digestive tract complications. He has a history of diverticulitis. Is there any addendum to either of these two meds to eliminate this complication.

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    Replies
    1. Hi Kim,

      Some people get belly problems from these meds. Others don't. There are a few things that help with the GI side effects from pirfenidone: taking it with food, slowly increasing the dose, sometimes taking other medications to help treat side effects. Certainly worth discussing this with his doctors.

      Best of luck.

      Dave Lederer

      Delete
  4. Hi,

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    ReplyDelete