Benzinga | Jun 22, 2021 01:49PM EDT

Halozyme Announces Janssen Receives European Marketing Authorizations For DARZALEX (daratumumab) Subcutaneous Formulation For Newly Diagnosed Systemic Light-Chain Amyloidosis And Pre-Treated Multiple Myeloma

Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Commission (EC) has granted the Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX(r) SC in the European Union. The first authorization is for the use of DARZALEX(r) SC in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adults with newly diagnosed systemic light-chain (AL) amyloidosis. The approval makes the DARZALEX(r) SC based regimen the first approved therapy for AL amyloidosis in Europe. The second authorization is for the use of DARZALEX(r) SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy.

"We are pleased that Janssen received European Commission marketing authorizations for these important new indications," said Helen Torley, president and chief executive officer at Halozyme. "These authorizations will provide new treatment options for certain AL amyloidosis and multiple myeloma patients in Europe."

DARZALEX(r) SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE(r) drug delivery technology.