New FDA Approvals: FDA Approves BioLineRx’s Aphexda

Sept. 8: The FDA approved BioLineRx Ltd.’s Aphexda (motixafortide) in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in people with multiple myeloma. The agency gave the agent orphan drug designation. Dosing for Aphexda is 1.25 mg/kg based on actual body weight via subcutaneous injection after filgrastim has been administered daily for four days and 10 to 14 hours prior to the start of apheresis. The drug’s price is $5,900 per vial, and the company has said that it expects most patients will need two vials.

Sept. 8: The FDA expanded the label of Sandoz Inc.’s Hyrimoz (adalimumab-adaz) to include the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s TNF inhibitor Humira (adalimumab) on Oct. 30, 2018. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The agent is available in a low-concentration, citrate-free version of its reference drug. The product launched in July with two wholesale acquisition costs: a branded version with a WAC of $6,576 and an unbranded one for $1,315 for a carton of two syringes or autoinjectors.