home
RSS
FDA committee recommends 2nd new hepatitis C drug for approval
April 28th, 2011
04:20 PM ET

FDA committee recommends 2nd new hepatitis C drug for approval

A Food and Drug Administration advisory committee is unanimously recommending approval of a second new treatment–in as many days–for hepatitis C genotype 1 infection in adults with liver damage who have not been treated or whose treatment failed. Hepatitis C is a chronic viral disease that causes inflammation and swelling of the liver.

The drug, telaprevir, is a new class of protease inhibitor manufactured by Vertex Pharmaceuticals. It too would be used in combination with ribavirin and peginterferon–the current standard of care. Telaprevir also prevents the virus from replicating, and studies show the three-drug cocktail is more effective than the two-drug regimen.

"We are thrilled with today's FDA Committee decision," said Dawn Kalmar, a Vertex spokeswoman. "This is an important step in our more than 15 year effort to bring telaprevir to people living with hepatitic C."

Wednesday, the committee unanimously approved boceprevir, a similar protease inhibitor manufactured by Merck & Co.

According to Vertex, about 79% of study patients who hadn't been treated and 85% of those who were treated but relapsed showed significant improvement when treated with telaprevir. The drug is administered orally 3 times a day with food.

"It's a stunning achievement that we will be able to cure nearly 80% of naive patients and probably close to the same number of relapsers," said Dr. Lawrence S. Freidman, Chair, Department of Medicine Newton-Wellseley Hospital. "There are so many positive aspects of this drug and for those of us who have been in the field, this is a very exciting time."

"The benefits far outweigh the risks," said Patrick Clay, Director, Dybedal Center for Clinical Research, Kansas City University of Medicine. "This is yet another step and that's all it is. This is a marathon not a sprint."

As with boceprevir, data for hard to treat patients like African Americans,  Hispanics and Latinos was very limited but those involved in the studies responded extremely well to therapy.

The most common side effects, according to Vertex and the FDA were rash and anemia. While panelists expressed concern, all felt the risks were manageable and stressed the importance of management programs that educate both patients and physicians.

Risks were not enough to sway KellyAnn Mann Hester, a mother of 4 and grandmother of 5 who was diagnosed with hepatitis C almost 20 years ago. Hester had a number of failed treatments and said she was once told she would not see her 5 year old son graduate high school. She participated in the telaprevir study and gave an impassioned plea for approval.  "I had no hope left that I was going to live with this disease. I was living to die," said Hester. "Now I'm living until I die because now I have many windows and avenues available to me that I did not have before.  Please approve this drug."

The FDA will now consider the committee's recommendation and decide if one or both of these drugs will be approved.


soundoff (19 Responses)
  1. animalluv40

    good for us hep c infected glad to here it

    April 28, 2011 at 20:57 | Report abuse | Reply
  2. buffalo

    I have HepC. Unless a lot has changed, these "cures" are often worse than the Hep C itself. Depression? hair loss? rash? Anemia? I don't suffer ANY of these symptoms at present. Why would I want to take a "cure" and get them? Once again, the witch doctors at the drug companies come out with the "next best thing" and try to pawn it off on desperate people. Cure Cancer? Hold your breath!

    May 1, 2011 at 20:13 | Report abuse | Reply
  3. luis rizo

    hola

    me dirijo a usted dr sanjay gupta para comentar acerca de un sistema de sannacion radionico ayurveda para la sanacion de el parkinson sida cancer y otras enfermedades concideradas incurables , pongo a su disposicion de manera totalmente gratuita el sistema solo proporcioneme una direccion e mail para mandarle el archivo , me interesa mandarle tambien informacion a michal j fox del mismo , quedo a sus ordenes luis rizo balderas

    May 14, 2011 at 12:07 | Report abuse | Reply
  4. Used Cisco Reseller

    I enjoy, cause I discovered exactly what I was taking a look for. You have ended my four day long hunt! God Bless you man. Have a nice day. Bye

    August 11, 2012 at 06:43 | Report abuse | Reply
  5. zortilo nrel

    Very interesting points you have observed, thanks for putting up.

    http://www.zortilonrel.com/

    December 28, 2020 at 13:57 | Report abuse | Reply
  6. zortilo nrel

    Very interesting topic, thank you for putting up.

    http://www.zortilonrel.com/

    December 30, 2020 at 19:48 | Report abuse | Reply
  7. tengeri szállítmányozás Europa-Road Kft

    I've been browsing on-line more than 3 hours nowadays, yet I never discovered any attention-grabbing article like yours. It is lovely price sufficient for me. In my view, if all website owners and bloggers made just right content material as you did, the web will be much more helpful than ever before. "No nation was ever ruined by trade." by Benjamin Franklin.

    https://europa-road.eu/hu/tengeri-szallitmanyozas.php

    February 9, 2021 at 03:23 | Report abuse | Reply
  8. http://www.fokuszpalyazat.hu/

    When I originally commented I clicked the -Notify me when new comments are added- checkbox and now every time a comment is added I get 4 emails with the identical comment. Is there any way you can take away me from that service? Thanks!

    http://www.fokuszpalyazat.hu/

    February 9, 2021 at 05:10 | Report abuse | Reply
  9. pc repair

    You should take part in a contest for one of the best blogs on the web. I will recommend this site!

    https://cds-consultants.com

    February 21, 2021 at 05:31 | Report abuse | Reply
  10. frolep rotrem

    As a Newbie, I am continuously searching online for articles that can benefit me. Thank you

    http://www.froleprotrem.com/

    February 24, 2021 at 17:24 | Report abuse | Reply
  11. zortilo nrel

    Some truly interesting points you have written.Helped me a lot, just what I was looking for : D.

    http://www.zortilonrel.com/

    March 10, 2021 at 18:53 | Report abuse | Reply
  12. zortilonrel

    I'm not sure why but this web site is loading extremely slow for me. Is anyone else having this issue or is it a issue on my end? I'll check back later on and see if the problem still exists.

    http://www.zortilonrel.com/

    March 21, 2021 at 14:28 | Report abuse | Reply
  13. Bud Capua

    Hi there very cool blog!! Guy .. Excellent .. Amazing .. I'll bookmark your blog and take the feeds additionally…I am satisfied to search out a lot of useful information here within the publish, we want develop more strategies in this regard, thanks for sharing.

    http://www.froleprotrem.com/

    March 25, 2021 at 03:09 | Report abuse | Reply
  14. Ty Qualey

    I was very pleased to find this web-site.I wanted to thanks for your time for this wonderful read!! I definitely enjoying every little bit of it and I have you bookmarked to check out new stuff you blog post.

    http://www.froleprotrem.com/

    March 25, 2021 at 08:23 | Report abuse | Reply
  15. Gsa Ser Proxies

    Heya are using WordPress for your blog platform? I'm new to the blog world but I'm trying to get started and create my own. Do you require any html coding expertise to make your own blog? Any help would be really appreciated!

    https://dreamproxies.com/buy-proxies/5000-private-proxies/

    April 8, 2021 at 03:33 | Report abuse | Reply
  16. Hai Jardon

    As I web site possessor I believe the content material here is rattling great , appreciate it for your hard work. You should keep it up forever! Good Luck.

    https://extraproxies.com/tag/puncturing/

    April 16, 2021 at 13:49 | Report abuse | Reply
  17. stornobrzinol

    I have been absent for a while, but now I remember why I used to love this web site. Thank you, I will try and check back more frequently. How frequently you update your web site?

    http://www.stornobrzinol.com/

    May 13, 2021 at 22:42 | Report abuse | Reply
  18. stornobrzinol

    great put up, very informative. I'm wondering why the other specialists of this sector don't notice this. You should proceed your writing. I'm confident, you have a great readers' base already!

    http://www.stornobrzinol.com/

    May 15, 2021 at 09:10 | Report abuse | Reply
  19. buy cbd gummies

    A big thank you for your post.Really thank you! Awesome.

    https://bit.ly/3x2ZiGJ

    June 29, 2021 at 19:52 | Report abuse | Reply

Post a comment


 

CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

Advertisement
About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.

Archive
April 2011
M T W T F S S
 123
45678910
11121314151617
18192021222324
252627282930  
  • An error has occurred, which probably means the feed is down. Try again later.