New Treatment for Crohn's from CCFA News

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CatMan
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Date Joined Jun 2006
Total Posts : 289
   Posted 5/1/2008 11:21 AM (GMT -7)   
UPDATE 2-U.S. FDA approves UCB bowel drug, with caution

Last Updated: 2008-04-22 15:39:17 -0400 (Reuters Health)

WASHINGTON (Reuters) - U.S. health officials on Tuesday approved Belgian drugmaker UCB Inc's (UCB.BR: Quote, Profile, Research) experimental drug to treat Crohn's disease, but they warned of serious potential side effects.

The U.S. Food and Drug Administration said it approved the drug, called Cimzia, to treat adult patients with moderate to severe versions of the inflammatory bowel disease who have not responded to conventional treatments.

More than 1 million people worldwide suffer from the chronic condition, according to the agency. Symptoms of Crohn's disease include diarrhea, fever, rectal bleeding, cramping and abdominal pain.

Regulators cautioned that the drug comes with increased risk for "serious adverse effects, including serious infections that can lead to hospitalization or death," the FDA said.

Rival Abbott Laboratories (ABT.N: Quote, Profile, Research) sells a drug to treat Crohn's disease called Humira, which carries similar warnings about risk of malignancies and fatalities.

UCB needs potential new blockbusters after expiration of patent protection on allergy medicine Zyrtec last year. Keppra, its epilepsy drug, is set to lose its protection in 2009.

The company had hoped to gain approval for Cimzia in Crohn's early last year, but announced in December 2006 that the FDA had required additional information. The start of a new trial, and the subsequent failure to gain approval for Cimzia in Europe, sparked a sharp fall in UCB's share price.

Some analysts had even questioned whether Cimzia would ever get to market or, if it did, that it would be far behind its competitors.

A company spokeswoman said the company aimed to treat its first patient within 48 hours.

The drug, given as an injection, is one in a class known as tumor necrosis factor blocker drugs, which may cause lymphoma and other malignancies, it said.

Although no increased risk of tumors was seen in studies with Cimzia, those studies were short-term and UCB will be required to conduct further studies to determine the drug's long-term safety, FDA said.

The most common side effects reported with the drug include headache, upper respiratory infections, abdominal pain and nausea, the FDA said. (Reporting by Susan Heavey and Kim Dixon in Washington and Philip Blenkinsop in Brussels; Editing by Braden Reddall, Richard Chang)
Current Medications:

Pentssa, 1000 mg qid
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Trader Joe's Probiotic
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Remicade infusion; every 8 weeks
Klonopin
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Sarita
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Date Joined Mar 2005
Total Posts : 2486
   Posted 5/1/2008 11:29 AM (GMT -7)   
We are studying these tumor necrosis factor blockers in school right now.  Very complicated drugs!  And sometimes scary side effects.  But it's also scary to think of living with horrible Crohn's symptoms and not responding to other drugs.  The risk/benefit ratio has to calculated carefully!  Thanks for posting the link... 

Co-moderator - IBS Forum

Please always remember to consult your medical professional regarding your medical questions; this forum is intended to provide patient-to-patient support. Although some of us have healthcare backgrounds, we cannot diagnose or treat patients on the board.


CrohnieToo
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Date Joined May 2003
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   Posted 5/1/2008 11:29 AM (GMT -7)   
Evidently the Europeans are smarter than we are. Or less greedy than the FDA. These new drugs should HAVE to prove MORE EFFECTIVE than an approved related drug instead of more effective than a d*mn placebo! ESPECIALLY when there are KNOWN SERIOUS side effects.
Some people are like Slinkies... Not really good for anything, but they still bring a smile to your face when you push them down a flight of stairs.


ivy6
Elite Member


Date Joined Sep 2005
Total Posts : 10404
   Posted 5/1/2008 6:16 PM (GMT -7)   
C2 said,

"These new drugs should HAVE to prove MORE EFFECTIVE than an approved related drug instead of more effective than a d*mn placebo! ESPECIALLY when there are KNOWN SERIOUS side effects."

But C2, isn't it good that those of us who have reacted to one biologic at least have access to other medications that are as effective as Rem and Humira?

I know we want new and better drugs, but I think that extra options are good, even if they're no more effective than what we have already.

I.
Co-Moderator Crohn's Forum.


CrohnieYogi
Regular Member


Date Joined Oct 2006
Total Posts : 367
   Posted 5/1/2008 6:22 PM (GMT -7)   
I would have to agree with ivy. Also, if you've read other press releases, you will see that the side effects listed are along the same lines as those of humira and remi.

That said, I am still cautious, but optimistic that this drug will help someone.

Cookie's Wife
Regular Member


Date Joined Aug 2005
Total Posts : 299
   Posted 5/1/2008 7:34 PM (GMT -7)   
I was in the clinical trial and it DIDN'T work for me even before the possibility of getting the placebo. But like with any other drug for Crohn's what works for one may not work for the other.  I hope it works for someone that is having trouble finding a med that works!

April
 
If God brings you to it, He will bring you through it


CrohnieToo
Veteran Member


Date Joined May 2003
Total Posts : 9448
   Posted 5/2/2008 3:29 AM (GMT -7)   
My point is they only have to work better than a PLACEBO! They aren't matched against another drug to even be proven AS effective as that other drug. Its like using the CDAI to determine that the drug brought remission. The CDAI is no more capable of detecting true remission than a pile of poop. It can indicate the drug has brought RELIEF but NOT remission. Holding this disease to a low roar does improve quality of life, thank God, BUT even at a low roar it is STILL DOING DAMAGE. Too many doctors are satisfied w/relief of symptoms w/o having a goal of TRUE REMISSION. YES, we sufferers want RELIEF, but we NEED true REMISSION. Unfortunately, we are so grateful when we DO get relief that we often don't even recognize when relief is not remission and we are satisfied w/relief.
Some people are like Slinkies... Not really good for anything, but they still bring a smile to your face when you push them down a flight of stairs.


CrohnieYogi
Regular Member


Date Joined Oct 2006
Total Posts : 367
   Posted 5/2/2008 6:04 AM (GMT -7)   
I totally agree with your point about patients being satisfied with relief and not remission. I think most patients don't realize their disease is not managed as well as it could be....

Another thing to look at with this drug (and other biologics) is they have shown mucosal healing. That is a huge deal when you think about it.

As for being matched against another drug....no drug company is going to do a head to head study. What if the data showed the competitor was actually better??

CrohnieToo
Veteran Member


Date Joined May 2003
Total Posts : 9448
   Posted 5/2/2008 9:09 AM (GMT -7)   
Its been done. Testing a drug head to head w/the competition. With an osteoporosis drug. And the new drug lost the first trial. Not ones to give up they are testing it in combination w/a different form of osteoporosis drug. Certainly patients stand to benefit most w/this type of testing/trialing/comparison.
Some people are like Slinkies... Not really good for anything, but they still bring a smile to your face when you push them down a flight of stairs.


ivy6
Elite Member


Date Joined Sep 2005
Total Posts : 10404
   Posted 5/2/2008 4:20 PM (GMT -7)   
I see what you mean, C2. Good point. Maybe if *both* kinds of testing were mandatory it would help us?

However, more testing could mean it takes longer for patients to be able to access the drug, and therefore a delay in companies reaping profits for any of their new medications. That delay might make them less willing to research and develop new treatments. People tend to want reasonably quick returns on their investments.

Hmmm.

I.
Co-Moderator Crohn's Forum.

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