Roche’s Gazyva (obinutuzumab) Receives FDA’s Breakthrough Therapy Designation for Lupus Nephritis

 Roche’s Gazyva (obinutuzumab) Receives FDA’s Breakthrough Therapy Designation for Lupus Nephritis

Roche’s Gazyva (obinutuzumab) Receives FDA’s Breakthrough Therapy Designation for Lupus Nephritis

Shots:

  • The FDA’s BT designation is based on P-II NOBILITY (NCT02550652) study assessing Gazyva in combination with mycophenolate mofetil/mycophenolic acid and corticosteroids vs PBO + MMF/MPO and corticosteroids in 126 patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis
  • The P-II NOBILITY study resulted in meetings its 1EPs & 2EPs i.e, complete renal response (CRR) @52wks. & improvement in overall renal responses and serologic markers of disease activity with no new safety signals respectively
  • Gazyva is mAb targeting CD20, act by attacking targeted cells both directly and together with the body’s immune system with its anticipated onset of P-III study in 2020

Click here to­ read full press release/ article | Ref: Roche | Image: Behance

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

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