FDA committee recommends omadacycline for approval
The FDA’s Antimicrobials Drug Advisory Committee has voted in favor of approving Paratek’s new antibiotic omadacycline for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, the company announced.
Omadacycline is a once-daily, IV and oral, broad-spectrum antibiotic in the tetracycline family.
“Omadacycline is a modernized tetracycline antibiotic with the potential to help address the urgent and growing need for new agents to treat serious community-acquired infections,” Evan Tzanis, chief development officer for Paratek, told Infectious Disease News. “If approved, omadacycline would be the first once-daily IV and oral antibiotic in more than a decade.”
Paratek said that as a new chemical class in the tetracycline family, omadacycline demonstrates activity against tetracycline-resistant bacteria.
“Omadacycline is related to the tetracycline drugs and many would consider it to be member of this drug class,” Jean Patel, PhD, D (ABMM), science team lead for the CDC’s antibiotic strategy and coordination unit, told Infectious Disease News. “It is important to note that omadacycline does have activity against bacteria that are resistant to older tetracyclines like doxycycline.”
According to Paratek, omadacycline was recommended for approval based on safety and efficacy results from phase 3 clinical trials.
“With once-daily dosing and bioequivalent IV and oral formulations, omadacycline may help facilitate early discharge from the hospital or in other cases, allow for safe and effective treatment in the outpatient setting,” Tzanis said. “Many of the newer agents are IV only, so the dual formulations with omadacycline may be a real advantage for prescribers and may offer a cost savings to hospitals.”
The FDA decision for IV and oral omadacycline for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia is expected in early October 2018. – by Marley Ghizzone
Disclosures: Tzanis works for Paratek Pharmaceuticals.