China Approves Vibativ for Severe Infections
Cumberland Pharmaceuticals’ antibiotic Vibativ (telavancin) injection has gained approval from China’s National Medical Products Administration (NMPA), offering a new treatment option for patients with severe bacterial infections
The approval comes after the company’s agreement with SciClone Pharmaceuticals granted it exclusive rights to register, promote and distribute this US Food and Drug Administration (FDA)-approved injection in China. The antibiotic, which can be administered once a day without the need for therapeutic drug monitoring, aims to reduce healthcare professionals’ exposure to patients. The companies plan the injection’s launch in the country in 2025.
As an injectable anti-infective, Vibativ is tailored to combat ventilator associated and hospital-acquired pneumonia caused by various Gram-positive bacteria. It is also aimed against complicated skin and skin structure infections (cSSSIs), such as those caused by methicillin-resistant staphylococcus aureus (MRSA). Discovered through a dedicated research programme, Vibativ targets serious infections caused by Staphylococcus aureus (S aureus) and other Gram positive bacteria, encompassing both MRSA and methicillin-susceptible strains. The injection has in vitro potency and bactericidal activity within six hours
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