Category: Benlysta

  • AZ’s Saphnelo is cleared in EU, challenging GSK’s Benlysta

    lupusAstraZeneca’s Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more than 10 years. The European Commission has cleared the type I interferon receptor antagonist antibody as an add-on therapy to standard treatment for adults with moderate to severe SLE, four […]

  • Voclosporin (Lupkynis) for Lupus Nephritis

    Date:  August 23, 2021 Issue #:  1631 Summary:  Voclosporin (Lupkynis – Aurinia), an oral calcineurin inhibitor, has been approved by the FDA for use in combination with the antimetabolite immunosuppressant mycophenolate mofetil (Cellcept, and generics) and a corticosteroid for treatment of adults with active lupus nephritis. It is the first calcineurin inhibitor to be approved […]

  • ViewPoints Interview: GSK’s Steve Bradford Shares Insight on Benlysta

    In an interview with PharmaShot, Steve Bradford, Vice President, Medicines Commercialization Leader at GSK shed light on the US FDA’s approval of Benlysta as the first and only approved treatment for both lupus and adult patients with active LN who are receiving standard therapy. Shots: The US FDA has approved GSK’s Benlysta (belimumab) as the […]

  • GSK’s Benlysta claims first FDA okay for lupus kidney damage

    GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the […]