Halozyme Therapeutics
High-Volume Subcutaneous Injection in Seconds
Halozyme Therapeutics’ proprietary high-volume auto-injector (HVAI) represents a quantum jump in auto-injector delivery capabilities. Typically, biologics delivered subcutaneously through auto-injectors are restricted to doses of 1-2 mL or require long delivery times at slow rates for higher volumes. But in a breakthrough feasibility study this year, Halozyme’s HVAI paired with the company’s drug delivery technology, ENHANZE®, demonstrated the capability of administering 10 mL of a biologic in 30 seconds via subcutaneous injection.
In the past, rapid subcutaneous injection was limited due to hyaluronan, a molecule that inhibits fluid dispersion in the subcutaneous space. However, Halozyme’s ENHANZE® is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20) that temporarily increases the permeability of the tissue under the skin, allowing space for the biologic to enter and be rapidly dispersed and absorbed into the bloodstream.
For example, this summer the FDA approved the use of ENHANZE® with argenx’s drug VYVGART Hytrulo to treat generalized myasthenia gravis (gMG), which allows the drug to be delivered by subcutaneous injection instead of IV, reducing treatment time from one hour to under 90 seconds. This year, Halozyme and Roche also announced the approval of Tecentriq SC, the first-ever subcutaneous immunotherapy for cancer in Great Britain. Co-formulated with the ENHANZE® drug delivery technology for patients with certain types of lung, bladder, breast, and liver cancer, the therapy is delivered in just seven minutes, compared to 30-60 minutes for a standard IV infusion. The treatment is up for FDA approval in 2024.
So far, ENHANZE® is used in seven commercialized products across more than 100 global markets with another 14 products in development.
