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

[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!! 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!!!!