Halozyme Therapeutics Inc. (NASDAQ:HALO) Announce That The EMA Has Approved Jannsen’s Subcutaneous DARLEX Formulation

Halozyme Therapeutics Inc. (NASDAQ:HALO) has announced that Janssen-Cilag International has received marketing approval from the European Commission for DARZALEX (daratumumab) which is a subcutaneous formulation for the treatment of multiple myeloma in adult patients. This is for all the currently authorized DARZALEX intravenous formulation application in relapsed/refractory and frontline settings.

Subcutaneous DARZALEX receives EU approval

The authorization of DARZALEX comes after the European Medicines Agency’s CHMP’s Positive Opinion issued in April 2020. The subcutaneous formulation is given as a fixed-dose in around there to five minutes, which is much less time compared to IV DARZALEX that is administered over several hours. Following the approval, patients that are currently receiving intravenous DARZALEX will have an alternative of switching to the subcutaneous formulation.

Dr. Helen Torley indicated that the company was delighted to have received marketing approval in the EU for SC formulation for DARZALEX. This gives DARZALEX a broad label barely weeks after receiving a positive opinion from CHMP. Helena added that SC DARZALEX can improve the treatment experience for patients with multiple myeloma and doctors across the EU. As a result, patients are expected to enjoy shorter treatment periods relative to when DARZALEX is administered intravenously, which takes time.

Two studies supported the marketing approval of DARZALEX

The marketing approval for DARZALEX was based on results from two studies that the company conducted. The first study was the Phase 3 non-inferiority COLUMBA study that compared the subcutaneous DARZALEX formulation to the intravenous formulations in patients with refractory/relapsed multiple myeloma. The other data that was considered was that from the second phase PLEIADES study (MMY2040) that evaluated the combination of DARZALEX and other standard multiple myeloma treatments.

The company announced topline COLUMBA study results in February 2019. Afterward, the company presented the results at the 2019 Annual American Society of Clinic Oncology Conference as well as the 24th Annual Congress of the European Hematology Association. The company presented updated results of the PLEIADES and COLUMBA studies in a poster session in December 2019 during the Annual 61st American Society of Hematology Meeting.