The supplemental new drug application was approved based on results of a phase 3 trial in which IV-to-oral delafloxacin met the primary end point of statistical non-inferiority to moxifloxacin.
The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Melinta Therapeutics' delafloxacin (Baxdela) for the treatment of adults with community-acquired bacterial pneumonia (CABP).
The approval is based on the results of a phase 3 randomized, double-blind study comparing the efficacy and safety of delafloxacin to moxifloxacin. The study results showed that IV-to-oral delafloxacin met the primary end point of statistical non-inferiority for early clinical response (ECR) at 96 hours (± 24 hours) after initiation in the intent-to-treat population with 88.9% ECR in patients who received delafloxacin compared to moxifloxacin (89.0%). Additionally, delafloxacin was generally safe and well-tolerated.
The sNDA follows FDA priority review based on the previous Qualified Infectious Disease Product designation.
“We are pleased to announce the approval of Baxdela for the treatment of CABP in adults,” Jennifer Sanfilippo, interim chief executive officer of Melinta, said in a statement. “As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives. As such, while we believe that Baxdela will play a significant role in the treatment of this potentially life-threatening illness, we are delaying the commercial launch of CABP until we have greater insight into our ability to secure additional sources of liquidity.”
The FDA approved delaflocaxin for the treatment of acute bacterial skin and skin structure infections in adults in June 2017.
"Some of our newer agents, omadacycline and delafloxacin, have obtained almost simultaneous approvals or simultaneous approvals for both ABSSSI and CABP. That speaks to 2 things…1) the illnesses are largely driven by gram-positive agents. So in skin infections, you have Staph aureus and Streptococcus, either group A or group B or other beta-hemolytic Strep. In community-acquired bacterial pneumonia, again, it’s a Streptococcus pneumoniae followed by Staph aureus," he said. "Gram-negatives take on a more important role in both of those illnesses as the patient becomes more comorbid, more immunocompromised, and so they have relatively similar spectra to cover: Staphs and Streps in both settings."
"Skin, pneumonia, and UTI are the 3 most common infections that we see in hospitals," he continued. "And so getting drugs through the approval process through registration trials, it's easier to go for infections that are very easy to enroll in, ie, common ones like pneumonia and skin, in order to get a drug onto the marketplace rather than starting with an illness that might actually have a larger medical need for newer antibiotics but would be harder to enroll patients in, like bacteremias or osteomyelitis and so on. And so hence the very similar crossover and simultaneous approval for drugs with community-acquired bacterial pneumonia and ABSSSI."