GSK’s Benlysta (belimumab, IV) Receives EC’s Approvals as the First Biologic to Treat Lupus in Children

 GSK’s Benlysta (belimumab, IV) Receives EC’s Approvals as the First Biologic to Treat Lupus in Children

GSK’s Benlysta (belimumab, IV) Receives EC’s Approvals as the First Biologic to Treat Lupus in Children

Shots:

  • The EC’s approval is based on PLUTO study assessing Benlysta (10 mg/kg IV) + SoC vs PBO + SoC in 93 children aged 5 – 11yrs. and 12 – 17yrs. with systemic lupus erythematosus for 1yr. The EC’s approval follows recent approval in the US & Japan 
  • The PLUTO study result: improvement in disease activity as assessed by SLE responder index response rate (52.8% vs 43.6%); patients with at least one AE and a serious AEs (79.2% and 17.0% vs 82.5% and 35.0%); PK & benefit-risk profile is consistent with adult SLE
  • Benlysta is mAb targeting BLyS and has received approval for adults with SLE in the EU as an IV formulation in Jul’2011 and SC formulation in Nov’2017

Click here to­ read full press release/ article | Ref: GSK | Image: Montco. today

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post