A formulation of daratumumab that will allow it to be injected subcutaneously is under development and will soon start testing in a clinical trial.
This news came out in a press release put out earlier this week by one of the companies (Halozyme) that is helping in the development of the new formulation. Daratumumab was originally developed by Genmab and is now being co-developed with Johnson & Johnson, which will market the potential new myeloma therapy if it is eventually approved by regulatory authorities.
Daratumumab has not yet been filed for approval in any country, but there are expectations that such filings will be made in the coming months. (Follow this link for daratumumab-related news articles at The Beacon.)
It appears that the subcutaneous version of daratumumab will need to be produced differently than the IV version. This is often the case with drugs, where versions of the drug that are administered differently are usually manufactured differently.
It is not the case, however, with Velcade. The Velcade that can be given intravenously or subcutaneously is produced in the same way and comes in the same vial and box.
Here is more information about the subcutaneous daratumumab news from the Halozyme press release from earlier in the week:
Halozyme Therapeutics Reports Selection Of First Product Candidate Under Janssen Collaboration
Mar 10, 2015 9:00 am
San Diego, CA (Press Release) – Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported today that Genmab A/S announced plans for a Phase 1 clinical trial of a subcutaneous formulation of the anti-CD38 antibody daratumumab using the ENHANZE™ technology. In December 2014, Janssen Biotech, Inc. (Janssen) entered into an agreement with Halozyme Therapeutics for the purpose of developing and commercializing products combining proprietary Janssen compounds with Halozyme's ENHANZE technology. This agreement has the potential to lead to the development of a subcutaneous formulation of daratumumab. Daratumumab is being developed under a collaboration between Janssen and Genmab A/S since August 2012 when Genmab granted Janssen an exclusive worldwide license to develop, manufacture, and commercialize daratumumab ...
|
||
Independent, up-to-date news and information for the multiple myeloma community. |
|
