Date: 2018-09-20
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Actemra®/Roactemra®
Compound: tocilizumab
Therapeutic area: Rare diseases
Action mechanism:
- monoclonal antibody. Actemra®/Roactemra® is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R).
Company: Roche (Switzerland) Genentech (USA - CA)
Disease: systemic juvenile idiopathic arthritis (SJIA)
Latest news:
- • On September 20, 2018, the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the subcutaneous (SC) formulation of RoActemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients one year of age and older. RoActemra® can be given alone or in combination with methotrexate (MTX) in patients with sJIA. In 2011, the European Commission approved the intravenous (IV) formulation of RoActemra® for patients two years of age and older with active sJIA.
- The positive CHMP opinion is based on data from the WA28118 study, a 52-week, open-label, multicentre, phase Ib pharmacokinetic (PK)/pharmacodynamic (PD) bridging study designed to determine the appropriate dosing regimen of RoActemra SC across a range of body weights (BWs) in children with sJIA. The study enrolled 51 patients aged one to 17 years with sJIA and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids who were either RoActemra naive or were receiving RoActemra IV with adequate disease control. RoActemra SC was administered open label according to a BW-based dosing regimen: sJIA patients weighing <30 kg received 162 mg of RoActemra every two weeks or 10 days and sJIA patients weighing >=30 kg received 162 mg of RoActemra every week for 52 weeks. Model-computed PK and PD parameters, and safety were assessed.
- In general, the safety observed for RoActemra SC was consistent with the known safety profile of RoActemra IV, with the exception of injection site reactions (ISRs). A higher frequency of RoActemra SC patients experienced ISRs, 41% (21/51) compared to patients treated with RoActemra SC for other approved indications. All ISRs reported were non-serious, and none required patient withdrawal from treatment or dose interruption.
- The efficacy of RoActemra SC in children one to 17 years of age is based on PK exposure and extrapolation of established efficacy of RoActemra IV in sJIA patients and RoActemra SC in patients with RA.
- • On September 13, 2018, Roche announced that the FDA has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate (MTX) in patients with sJIA. In 2011, FDA approved the intravenous (IV) formulation of Actemra for patients two years of age and older with active sJIA.
- The approval is based on data from the JIGSAW-118 study, a 52-week, open-label, multicenter, phase 1b pharmacokinetic (PK)/pharmacodynamic (PD) bridging study designed to determine the appropriate dosing regimen of Actemra SC across a range of body weights (BWs) in children with sJIA.[2] The study enrolled 51 patients aged one to 17 years with sJIA and inadequate response to NSAIDs and corticosteroids who were either Actemra naive or were receiving Actemra IV with adequate disease control. Actemra SC was administered open label according to a body weight -based dosing regimen: sJIA patients weighing <30 kg received 162 mg of Actemra every two weeks or 10 days and sJIA patients weighing >=30 kg received 162 mg of Actemra every week for 52 weeks. Model-computed PK and PD parameters, and safety were assessed.
- • On May 20, 2011, the CHMP has adopted a positive opinion for an application for extension of the therapeutic indications, adding a new treatment option for a medicine that is already authorised in the European Union (EU), for RoActemra® (tocilizumab), from Roche Registration Ltd, to include the treatment of systemic juvenile idiopathic arthritis in patients from two years of age and older.
- • On April 15, 2011, the FDA has approved Actemra® for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older. Actemra® can be given alone or in combination with methotrexate in patients with SJIA. It has already been approved by the FDA on Jan. 8, 2010, for treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to other approved therapies.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-04-15/2018-09-13 (SC)
UE authorization: 2011-08-03
Favourable opinion UE: 2011-05-20/2018-09-20 (SC)
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
