|The status of TMB-355
Nov 30, 2013
Hi Nelson, Could you update the status of TMB-355? Thanks you very much.
| Response from Mr. Vergel
The status of this drug is still up in the air. It is no longer called TMB-355 but ibalizumab. Ibalizumab's long road
TaiMed has notified doctors that they will be stopping shipment of their monoclonal antibody to patients receiving it via compassionate use in January due to shortages. They have applied for orphan drug status for deep salvage but were denied it by the FDA since the FDA thinks that people not in salvage can take the drug. For orphan drug status a drug has to be useful to less than 200,000 people which salvage clearly qualifies. Orphan drug can remove barriers in numbers and funding. They have little funding to proceed with studies needed to get the drug approved and are still looking for a company that may buy the rights of the product. They are spending money trying to prove that their drug has good PK for monthly subcutaneous injection to entice companies like ViiV to buy the rights (ViiV may be the first company to have a once a month injectable regimen in cooperation with Jansen and hopefully another company).
This drug has saved my life and there may be about 50-75 people taking it in the United States as part of an extension of Taimed's phase 2 study or as compassionate single patient TIND access.
Activists are now considering going to the FDA to request special consideration for this important drug that can help people with advanced multidrug resistance. Stay tuned since this story is just unraveling.
I hope you are not waiting for this drug. Let me know if you want to get involved by visiting
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