Genentech Receives FDA approval for Actemra SC for the Treatment of Active Systemic JIA in patients aged ≥2 yrs.

Shots:

• The FDA approval is based on P-I JIGSAW-118 (N=51) study assessing PK/PD with appropriate dosage regimen of Actemra SC (aged <17yrs) with range of BWs (weight <30 kg administering 162 mg BID for 10 days; weight ≥30 kg administering 162 mg qw for 52 wks.) in children with sJIA
• Actemra SC treated patients demonstrated 41% ISRs vs patients treated with Actemra SC for other approved indications. Actemra’s SC efficacy is based on PK disclosure and extrapolation evaluated from Actemra IV & Actemra SC in sJIA & RA patients respectively
• Actemra can be administered alone or in combination with MTX in sJIA patients. Actemra IV was approved by FDA in 2011 for patients aged ≥2 yrs. with sJIA

Click here to read full press release/ article | Ref: Genentech | Image: CNN