FDA approves Rituxan for Wegener's, MPA

[marlo511]

In case you didn't see the news late yesterday:

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).

"For the first time, people with Wegener's Granulomatosis and Microscopic Polyangiitis have a medicine that the FDA has approved for the treatment of these rare and relapsing diseases," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We are committed to following the science and focusing on diseases of high unmet medical need, including orphan conditions. Today's approval is an important example of how the scientific community can work together to advance science and treatment options for orphan diseases." ....

MORE>> FDA approves Rituxan-corticosteroid combination for Wegener's Granulomatosis and Microscopic Polyangiitis (http://www.news-medical.net/news/20110420/FDA-approves-Rituxan-corticosteroid-combination-for-Wegeners-Granulomatosis-and-Microscopic-Polyangiitis.aspx)

[Chris G]

This is awesome news for everyone!! This should mean that the insurance companies can no longer deny the treatment, right???

Thanks for posting.

[Sangye]

It is amazing news. I don't know if insurance can still force you to do ctx first though. It's so much cheaper that I bet they'll try. But it is true that they cannot deny rtx by arguing that it's not FDA-approved. This is a major step forward for treating Wegs.

[TBulger]

I just saw the announcement! I hope this will make it easier for all of those having difficulties with insurance companies.

[aewaustin]

YAY!!!! I just finished my 4th of 4 iv's of RTX on Monday and it has been a miracle drug for me. So excited that everyone else will have an easier time getting approval for this.

[Chris G]

I'm glad the rtx is working for you Anna! Any side effects?

[drz]

YAY!!!! I just finished my 4th of 4 iv's of RTX on Monday and it has been a miracle drug for me. So excited that everyone else will have an easier time getting approval for this.
Congratus to you!! :thumbsup: Are you now in remission?

[drz]

This is awesome news for everyone!! This should mean that the insurance companies can no longer deny the treatment, right???

Thanks for posting.

It will take away one of their excuses but they may still try deny it for some other non-valid reason, like it costs too much and there are cheaper alternatives that might work, so lets try all the cheap ones first.

[aewaustin]

Chris - Only side effects are that I have night sweats the night of the infusion, so much that I have had to change clothes twice during the night.

drz - I was not on any medicines when I got the first iv and was so weak that I could hardly function after 3pm each day and it was a really hard time as I was getting weaker each week. I went rapidly downhill for the month of March, and then got the first infusion 3/25/11. When I had the first iv it made a big difference in 24 hours, so I was thrilled, two weeks later I was able to walk/run 3 miles at our local lake (previously I had not been able to do anything physical for two months, and I am a runner so that was hard). Now about 4 weeks in I am totally functional, back at work full time and am working out every day. BUT my labs have not changed, I still have 3+ blood in my UA's, that is the only test to show if my Weg's is active. So remission is a bit away for me, but just wanted to explain that even though I am not in remission, the RTX truly has been a miracle for me... My doctor said that she is looking at the 8 week mark for my labs to change...

[Brooke]

Awesome News!!!! Anna - that is awesome the Rituxan is working so well for you!!! Yippie!!!!

[drz]

Chris - Only side effects are that I have night sweats the night of the infusion, so much that I have had to change clothes twice during the night.

drz - I was not on any medicines when I got the first iv and was so weak that I could hardly function after 3pm each day and it was a really hard time as I was getting weaker each week. I went rapidly downhill for the month of March, and then got the first infusion 3/25/11. When I had the first iv it made a big difference in 24 hours, so I was thrilled, two weeks later I was able to walk/run 3 miles at our local lake (previously I had not been able to do anything physical for two months, and I am a runner so that was hard). Now about 4 weeks in I am totally functional, back at work full time and am working out every day. BUT my labs have not changed, I still have 3+ blood in my UA's, that is the only test to show if my Weg's is active. So remission is a bit away for me, but just wanted to explain that even though I am not in remission, the RTX truly has been a miracle for me... My doctor said that she is looking at the 8 week mark for my labs to change...

That is an amazing recovery and we envy you. RTX was the first drug they tried for me and it either didn't work at all or else was working too slowly so they switched to CTX. It took many months to attain a drug induced remission and then I had a flare a month later. I think I will be considered back in remission after my next lab results but still struggle to walk three blocks with a cane.

Thank you for posting such encouraging and uplifting news that can lift the spirits of our new comers. I hope more stories like yours will make it easier for people to get RTX treatment in the future and have such great results too.

[aewaustin]

drz - I should have mentioned this before... This is my second round... I did the full Cytoxan/Imuran deal from 1992-1994. I then have had Weg's just a little bit out since 2003 and then it flared big in December 2010, but I am so difficult to diagnose that I waited too long to go to Cleveland. Finally got to Cleveland at the beginning of March and then got the iv at the end of the month. So I was really miserable and frustrated from Dec-March until I got the RTX this go round. But yes, since I have gotten the RTX I do consider myself very fortunate that it works for me... I feel for everyone that has a hard time getting into remission.

Brooke - Thanks :)

[renidrag]

This is incredible news.

[ArlaMo]

Yay, Anna! So good to hear that the rtx is working well for you. Hope you see the lab numbers come in line soon as well!

[Sangye]

That's great news, Anna. Your labs will be fine, just give it time. You wouldn't be feeling so well if the Wegs were not responding.

[marta]

Awesome news, thanks for posting this.

Anna, here's to running some sick trails together while we're healthy as horses. I'll work hard to get good enough to keep up to you. Treadmill's coming in on the 25th. :w00t::w00t:
RTX ROX!!!!:w00t:

[elephant]

That is great news Anna!

[Palmyra]

GREAT news to hear Anna. So glad your strength is returning. Alison has similar quick results that are 'positive'. They administer a pretty powerful punch of IV solumedrol along with those RTX infusions, so that might explain the night sweats.
Alison is feeling better as well, and has a new part time job lined up. Three cheers for RTX!

[aewaustin]

Thanks everyone :) Have to admit I am feeling so lucky to have an easy go this time around, really feel like RTX is a miracle drug, and am so thankful for it. Now just to get off this freaking prednisone...

Marta, right now if you can walk you can keep up with me :) But today I rejoined the gym, so I am getting geared up! I am so up for actually running some trails soon!!! Enjoy that treadmill!