Roche Reports EMA and FDA’s Acceptance of Marketing Application for Satralizumab to Treat Neuromyelitis Optica Spectrum Disorder

Roche Reports EMA & FDA’s Acceptance of Marketing Application for Satralizumab to Treat Neuromyelitis Optica Spectrum Disorder

Shots:

  •  The EMA has validated MAA for Satralizumab and granted it accelerated assessment to treat adult and adolescent patients with NMSOD. The US FDA has also accepted the BLA for Satralizumab with the expected CHMP & FDA’s decision in 2020
  • The marketing application is based on two P-III SAkuraStar and SAkuraSky studies assessing Satralizuma as a monothx. & in combination with immunosuppressant therapy, respectively in AQP4-IgG seropositive and seronegative patients
  • Satralizumab is an investigational mAb targeting IL-6 and has received FDA’s BT designation for NMSOD in Dec’2018 with PR and ODD in the US, Europe and Japan. If EMA’s CHMP adopts a positive opinion, Satralizumab will be granted a MAA valid in all 28 member states of the EU

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Zee Business