Cumberland's Vibativ injection approved by China's NMPA

Cumberland Pharmaceuticals has reached a significant milestone with its antibiotic, Vibativ (telavancin) injection, receiving approval from China’s National Medical Products Administration (NMPA). This marks an important development for those suffering from severe bacterial infections, providing a new therapeutic option. The approval was secured through a collaboration with SciClone Pharmaceuticals, which holds exclusive rights to register, promote, and distribute Vibativ, already approved by the US Food and Drug Administration (FDA), within China.

Vibativ is a once-daily injectable antibiotic that does not require therapeutic drug monitoring, offering an advantage in clinical settings by minimizing healthcare professionals' direct exposure to patients during administration. SciClone Pharmaceuticals plans to launch this medication in China in 2025. Zhao Hong, CEO of SciClone Pharmaceuticals, emphasized the importance of Vibativ in their product portfolio, citing its potential to save lives by treating complicated infections that are otherwise difficult to manage. He expressed optimism for the impact this drug could have on patient care in China.

Vibativ is specifically designed to address ventilator-associated and hospital-acquired pneumonia, both caused by various Gram-positive bacteria. It is also effective against complicated skin and skin structure infections (cSSSIs), including those due to methicillin-resistant Staphylococcus aureus (MRSA). Developed through a focused research initiative, Vibativ targets serious infections caused by Staphylococcus aureus and other similar Gram-positive pathogens, covering both methicillin-resistant and methicillin-susceptible strains.

The antibiotic displays significant in vitro potency, with bactericidal activity observable within six hours of administration. Beyond China, Vibativ has already received approval for use in the Middle East and the United States for the treatment of adults suffering from hospital-acquired and ventilator-associated bacterial pneumonia, particularly when other treatments are found unsuitable. Additionally, it has been approved for addressing cSSSIs caused by susceptible Gram-positive bacteria.

This latest approval in China represents an expansion of Vibativ's global presence, reinforcing its role as a valuable tool in combating severe bacterial infections. Cumberland Pharmaceuticals continues to broaden its impact, previously marked by the US FDA’s decision to extend the labeling for another of its products, Caldolor, in May 2023. This expansion now includes its use in infants, demonstrating the company’s commitment to enhancing patient care across different demographics.

As Cumberland Pharmaceuticals and SciClone Pharmaceuticals prepare for the upcoming launch of Vibativ in China, it underscores a shared commitment to advancing healthcare solutions. The introduction of Vibativ is anticipated to significantly enhance treatment options for patients battling challenging infections, aligning with both companies' missions to provide high-quality medical products that improve healthcare outcomes.