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As the healthcare profession continues to face challenges with antibiotic resistance, drugmakers are developing novel antibiotics that will be effective against some of the worst infections. One drugmaker submitted New Drug Applications (NDAs) for approval of IV and oral delafloxacin (Baxdela) to FDA.
As the healthcare profession continues to face challenges with antibiotic resistance, drugmakers are developing novel antibiotics that will be effective against some of the worst infections.
For example, Melinta Therapeutics submitted New Drug Applications (NDAs) for approval of IV and oral delafloxacin (Baxdela) to FDA on October 24. Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA) and other serious skin infections.
The drug, which will likely receive priority review by FDA, could be approved by mid-2017.
“Baxdela, if approved, represents a potentially attractive treatment option for the nearly 3 million patients hospitalized annually in the US with serious skin infections,” said Eugene Sun, MD, CEO of Melinta. “These patients have a high rate of treatment failure, and frequently have underlying medical conditions that pose challenges to the choice of antibiotic.”
“We believe that Baxdela’s ability to treat challenging patients in hospitals will be a major driver of adoption,” said John Temperato, president and COO of Melinta. “If approved, we plan to support the introduction of Baxdela for the treatment of ABSSSI [acute bacterial skin and skin structure infection] with a focused acute-care hospital sales force. We believe we can further leverage the resources of such a sales team in the future as we seek to complete clinical studies and file applications to market Baxdela in additional indications such as community-acquired bacterial pneumonia and complicated urinary tract infections.”
Melinta is also assessing Baxdela in a clinical trial in patients with hospital-treated community-acquired bacterial pneumonia (CABP) and planning to initiate a clinical trial in complicated urinary tract infections (cUTI) in the near future.
Melinta’s NDAs are based on the results of two phase 3 studies, in which Baxdela met the primary end point of non-inferiority to a combination regimen of vancomycin plus aztreonam in reducing lesion size at the primary infection site at 48 to 72 hours.
In addition, Baxdela met the primary endpoint, the investigator assessment of clinical cure, for the European Medicines Agency (EMA) in both studies. Baxdela was shown to be well-tolerated among phase 3 study participants, with less than 1% of patients discontinuing for treatment-related adverse events.
The most common treatment-emergent adverse events in the phase 3 studies were diarrhea and nausea, which were generally mild and did not lead to treatment discontinuation. The treatment discontinuation rate due to treatment-related adverse events for patients treated with Baxdela in the phase 3 trials was 0.8%.
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