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