The US Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee has voted that DORIBAX™ (doripenem for injection) is safe and effective for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia. The committee voted in favor of the effectiveness of both 1-hour and 4-hour regimens.
While the final decision of approval for a drug lies in the hands of the FDA, the advisory committee makes recommendations after evaluating the data presented.
“We recognize that there is an important need for new antibiotics to treat these serious hospital infections,” says Joanne Waldstreicher MD, Global Head, Drug Development, Johnson & Johnson. “We look forward to further discussions with the FDA as they complete their review of DORIBAX for the treatment of hospital acquired and ventilator acquired pneumonia.”
Ventilator associated pneumonia is among an additional nine hospital-acquired conditions that CMS is proposing to no longer lead to higher Medicare payments. CMS will respond to comments on this proposal in a final rule to be issued on or before August 1. The rule would take effect in October.