From pre-clinical toxicokinetics to final dose recommendations, Certara helped Cubist Pharmaceuticals obtain regulatory approval of a new treatment for complicated infections.
At least two million people become infected with treatment-resistant bacteria each year in the US alone. At least 23,000 die as a direct result; many more lose their lives to other conditions complicated by the infections. With antibiotic resistance on the rise and a low rate of approvals for new antibiotics, there is urgent need to make new treatment options available to patients quickly, efficiently, and safely.
Certara experts in model-based drug development worked with Cubist Pharmaceuticals to bring the novel antibacterial agent Zerbaxa™ (ceftolozane/tazobactam) from pre-clinical studies through market approval to treat adults with complicated infections. Certara’s model-based analyses incorporated subject data collected in up to 10 clinical studies to support confident go/no go decisions, to improve understanding of drug exposure in diverse populations, and to anticipate and address regulatory needs for the drug’s expedited review and approval.