Crohn's Disease Forum » Books, Multimedia, Research & News » European Agency Recommends Approval of Stelara to Treat Crohn’s Disease


09-24-2016, 10:10 AM   #1
Crohn2357
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European Agency Recommends Approval of Stelara to Treat Crohn’s Disease

http://ibdnewstoday.com/2016/09/23/e...rohns-disease/

“The Committee for Medicinal Products for Human Use (CHMP), the scientific board of European Medicines Agency (EMA), has issued a positive opinion on Janssen’s Stelara (ustekinumab) for the treatment of patients with moderate-to-severe active Crohn’s disease, and for whom other therapies have failed.

The European Commission (EC) now will review CHMP’s opinion, with a final decision concerning marketing authorization for Stelara expected later this year. If the EC grants approval, Stelara will be marketed in the European Union and will be the first interleukin-12/23 inhibitor approved for Crohn’s disease.
…………………

Janssen also has submitted applications, currently under review, with the U.S. Food and Drug Administration seeking approval of Stelara for the treatment of moderate-to-severe Crohn’s disease.”
09-24-2016, 10:18 AM   #2
ronroush7
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Thanks for sharing this.
09-26-2016, 10:58 AM   #3
eleanor_rigby
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Stelera has now been approved today by the FDA: http://www.reuters.com/article/us-jo...-idUSKCN11W1LH

Does this mean people in the UK can use it?
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History:
2nd Generation affected

Symptoms since 08/2006 (age 17)

Emergency open bowel resection after perforation in 12/2011 (age 22) (wrongly diagnosed as burst appendix ). Three years remission following this unmonitored

Diagnosis:
Perforating small bowel Crohn's Disease 01/2016 (terminal ileum, duodenum)
Coeliac disease (age 26)

Meds:
50mg azathioprine (down from 75mg after my WBC dropped)
Gluten-free diet
09-26-2016, 11:59 AM   #4
my little penguin
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Woohoo!!!
Dosing is higher than psoratic arthritis as well
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DS - -Crohn's -Stelara -mtx
09-26-2016, 12:05 PM   #5
Maya142
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Stelara dosing:

STELARA® is the only treatment for Crohn's disease that starts with a weight-based, one-time intravenous (IV) infusion induction dose (260 mg [55 kg or less], 390 mg [more than 55 kg to 85 kg], or 520 mg [more than 85 kg]) to help reduce symptoms, followed by 90 mg subcutaneous maintenance injections every 8 weeks to help keep the symptoms under control. The first dose of STELARA® is an induction dose, administered intravenously, under the supervision of a healthcare professional. Subsequent maintenance doses are administered as a subcutaneous injection every 8 weeks, either by a healthcare professional or self-injected by the patient after proper training.
Very exciting!
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Mom of M (20)
diagnosed with Crohn's Disease at 16
Juvenile Idiopathic Arthritis at 12
Juvenile Ankylosing Spondylitis at 16

Mom of S (23)
dx with JIA at 14
Ankylosing Spondylitis at 18
09-26-2016, 04:12 PM   #6
Clash
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My son's maintenance dose is 90 mg injection every 8 weeks. His loading dose wasn't an IV infusion though. He had (3) 90 mg shot on day 0, (1) 90 mg shot on day 30 and then maintenance of 90mg every 8 weeks.
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C age 19
dx March 2012 CD

CURRENT MEDS: MTX injections, Stelara


Dx May 2014: JSpA
8/2014 ileocecectomy
9/2017 G tube

PAST MEDS: remicade, oral mtx, humira
11-11-2016, 03:07 PM   #7
eleanor_rigby
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Hi all, stelera has now been approved by the European Agency: http://seekingalpha.com/news/3223915...crohns-disease
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Crohn's Disease Forum » Books, Multimedia, Research & News » European Agency Recommends Approval of Stelara to Treat Crohn’s Disease
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