Cubist boosts antibiotics market presence
pharmafile | December 22, 2014 | News story | Sales and Marketing | Antibiotics, Zerbaxa, antimicrobial resistance, bacteria, cubist, infections, infectious diseases
Cubist has followed-up its successful European approval for a new antibiotic by winning an endorsement by the US FDA.
The regulator gave the company’s new antibiotic, Zerbaxa (ceftolozane/tazobactam), the go-ahead as a treatment for adults with complicated urinary tract infections or complicated intra-abdominal infections caused by certain kinds of bacteria.
The indication includes infections caused by some Gram-negative bacteria, which are highly adaptive and have multiple resistant mechanisms to antibiotics.
The EMA accepted Cubist’s applications for marketing authorisation in Europe for Zerbaxa in August 2014, along with an application for Sivextro (tedizolid phosphate) as a treatment for complicated skin and soft tissue infections, earlier in the year.
Public health threat
Studies are ongoing analysing the potential use of Zerbaxa to treat hospital-acquired bacterial pneumonia.
Robert Perez, Cubist’s president and chief operating officer, says: “Today is an important day for patients, and we are very pleased to arm physicians with Zerbaxa in the battle against Gram-negative bacteria, where few treatment options exist. The approval of Zerbaxa demonstrates the FDA’s commitment to make available new antibiotics that address this serious public health threat.”
“The widespread prevalence of dangerous Gram-negative pathogens together with their increased resistance to existing antibiotics has created a serious public health threat,” says Dr Louis Rice, a member of the board of directors of the Infectious Diseases Society of America. “Zerbaxa is a welcomed and much needed novel treatment for suspected or proven infections caused by susceptible Gram-negative pathogens.”
Lilian Anekwe
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