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New Drugs Online Report for etanercept
Information
Generic Name:
etanercept 
Trade Name: Enbrel 
Entry Type: Licence extension  
 
Developmental Status
UK: Launched 
EU: Launched 
US: Pre-registration (Filed) 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
Nov 11: Etanercept has not yet been approved in the US for use in children & adolescents with chronic moderate-to-severe plaque psoriasis as of March 2011. Amgen is conducting a US-based, long term open-label extension study of etanercept in paediatric pts (aged 4-17 years) with moderate-to-severe psoriasis (NCT00141921). This trial is due to be completed in 2019 [5].  
17/11/2011 15:43:58
Jul 11: EU positive opinion to extend the licence for etanercept (Enbrel) to include treatment of pts aged six yrs and above (from eight yrs) with plaque psoriasis [4]. 
22/07/2011 16:42:19
Approved in EU, Jan 09 (3) 
09/01/2009 15:36:42
Aug 08: Company has received a ´complete response´ letter from the FDA requesting additional information to support use in children with moderate-severe psoriasis. An FDA advisory panel voted 8 to 5 in favour of this indication in Jun 08, although most of the panel considered that it should be restricted to severe disease initially because of potential AE of infection and malignancies (2). 
23/09/2008 22:33:28
 
Trial or other data
Results at week 4 of a 48 week phase III study in children and adolescents with moderate-severe plaque psoriasis demonstrated that etanercept 0.8 mg/kg body weight significantly improved static physician global assessment (PGA) scores to clear or nearly clear status versus placebo (p < 0.005). At week-12, 53% and 13% of pts in the etanercept and placebo groups respectively had a PGA score of clear or almost clear status (P < 0.0001). 57% (n = 60) of paediatric pts treated with etanercept achieved PASI 75, compared with 11% (n = 12) of paediatric pts who received placebo (p ≤ 0.001). At week-36, after 24 weeks of open-label treatment during which all patients in the study received etanercept, PASI 75 was achieved by 68% (n = 71) of the patients initially treated with etanercept from the start of the study and 65% (n = 67) of those who initially received placebo from the start of the study (1) 
16/09/2008 15:58:52
 
Evidence Based Evaluations
SMC  http://www.scottishmedicines.org/files/advice/etanercept_Enbrel_Chronic_Plaque_Psoriasis_ABB_FINAL_April_2012_for_website.pdf 
AWMSG  http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=371&id=156345&F1EFC430-1143-E756-5C1E935428169EB7 
SMC  http://www.scottishmedicines.org.uk/smc/files/etanercept%20(Enbrel)%20Paediatric%20Abbreviated%20%20FINAL%20August%202009.doc%20for%20website.pdf 
AWMSG  http://www.wales.nhs.uk/sites3/Documents/371/20%20Non%20engagement%20notice.pdf 
   
References  
Available only to registered users
Category
BNF Category:
Drugs affecting the immune response (13.05.03)
Pharmacology: tumour necrosis factor antagonist  
Epidemiology:  
Indication: Psoriasis (paediatric) 
 
Method(s) of Administration
Subcutaneous 
 
Company Information
Name: Pfizer 
US Name: Pfizer 
 
NICE Information
In timetable: -