The Story of Oritavancin

Because of our shared mindset, ICPD scientists, often see opportunity where others do not. An example of this can be seen in the story behind oritavancin. A drug that may not be on the market today if it wasn’t for the science of PK-PD. Eli Lilly discovered oritavancin a quarter century ago. And like many long half-life drugs, they tried to develop it as a once daily regimen. But, for some reason, they couldn’t get it through
phase 3 trials. So in the early 2000’s, oritavancin’s development was taken over by Intermune and they too tried to develop it as a once daily regimen. Not seeing oritavancin’s potential, they decided to refocus their company and sell it to Targanta. Targanta continued developing it as a once daily regimen and invited us to work with them. However, after carefully evaluating the PK and PK-PD profiles of oritavancin, our teams realized that the solution was not to administer it as a series of small daily doses, but rather, as one big single dose. Targanta decided to shelve this idea now but explore it later, after the once-a-day regimen got approved. So they submitted it to the FDA for approval and, after many months, the FDA came back with a rejection. Daily doses of Oritavancin weren’t that effective. Seeing the potential in the previous PK-PD data, Oritavancin was then acquired by The Medicines Company. With ICPD’s support they conducted further clinical studies to put this novel regimen to the test. With the data from these trials in hand, the Medicine’s Company submitted oritavancin to the FDA as a single dose regimen and success. On August 19, 2014, the FDA approved oritavancin as the first single dose regimen antibiotic for complicated skin and skin structure
infections. Reflect on that for a moment. The exact same drug was submitted twice to the FDA, yet it was the dosing regimen —based on PK-PD science— that made the difference between
rejection and approval. This is what we mean when we say that PK-PD is essential to drug development. And in some cases, it is the difference that determines whether a valuable drug makes it to market and benefits patients.
After all, isn’t benefitting patients what drug development is all about?

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