European Agency Recommends Approval of Stelara to Treat Crohn’s Disease

[Crohn2357]

European Agency Recommends Approval of Stelara to Treat Crohn’s Disease

http://ibdnewstoday.com/2016/09/23/european-agency-recommends-approval-stelara-crohns-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.”

 

[ronroush7]

Thanks for sharing this.

 

[eleanor_rigby]

Stelera has now been approved today by the FDA: http://www.reuters.com/article/us-johnson-johnson-fda-idUSKCN11W1LH

Does this mean people in the UK can use it?

 

[my little penguin]

Woohoo!!!
Dosing is higher than psoratic arthritis as well

 

[Maya142]

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!

 

[Clash]

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.

 

[eleanor_rigby]

Hi all, stelera has now been approved by the European Agency: http://seekingalpha.com/news/3223915-johnson-and-johnsons-stelara-approved-europe-crohns-disease