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The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to EMA for expanded use of the SC formulation of Darzalex.
According to a Nov. 5, 2020 press release, the Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) for expanded use of the subcutaneous (SC) formulation of Darzalex.
The company is seeking European approval for the SC formulation of Darzalex (daratumumab) to be used in the treatment of patients with light chain (AL) amyloidosis, for which there are currently no approved therapeutic options available. The submission has been based on data from a Phase III study (ANDROMEDA) that evaluated the efficacy and safety of daratumumab SC in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) compared with bortezomib, cyclophosphamide, and dexamethasone (VCd) alone in the treatment of patients with AL amyloidosis.
“The current management of AL amyloidosis focuses on slowing production of amyloid protein and controlling symptoms; however, there are no EMA-approved therapies for this difficult-to-treat, rare disease,” said Dr Catherine Taylor, vice president, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag Middle East, in the press release. “If approved, adding daratumumab to this combination could address a significant unmet need and offer new hope to patients with AL amyloidosis, who have poor prognoses and have long been waiting for therapeutic options.”
“Daratumumab is an important foundational therapy in the treatment of multiple myeloma and now, on the basis of the ANDROMEDA study results, has shown that it can improve outcomes in a related plasma cell disorder, AL amyloidosis,” added Craig Tendler, vice president, Late Development and Global Medical Affairs, Janssen Research & Development, in the press release. “We are excited about the potential for daratumumab, as part of a regimen for newly diagnosed patients with AL amyloidosis to alter the poor prognosis of their disease and reduce organ damage, which is an unfortunate life-threatening complication of this serious disease.”