The recent first global approval of delafloxacin has been reviewed in detail in the First Global Approval report in Adis journal Drugs[1], based on the development milestones tracked in AdisInsight.[2]

In June, 2017, delafloxacin (Baxdela™), developed by Melinta Therapeutics (formerly Rib-X Pharmaceuticals), received its first global approval, for both intravenous and oral tablet formulations, in the US for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.[3] Delafloxacin is an anionic fluoroquinolone antibacterial that has activity against gram-positive and negative pathogens including methicillin-resistant Staphylococcus aureus (MRSA).

Delafloxacin was granted priority review because it has been designated a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012; this also grants the drug a five-year extension to any non-patent exclusivities in the US.[4]  The FDA approval was granted based on two phase III trials in approximately 1500 patients.[5] [6]

Dr. David Hooper, professor of medicine, Harvard University, Division of Infectious Diseases, Massachusetts General Hospital, explained that because antibiotic resistance is increasing, “physicians need more tools in the fight against this threat to modern medicine.”[4]

He went to say that, “Approval of new therapies like Baxdela, which is effective against MRSA and other serious pathogens, provides physicians another option in addressing the challenges of ABSSSI patients.”

Dr Eugene Sun, CEO of Melinta commented that delafloxacin would provide a good treatment option for the approximately 3 million patients who are hospitalised with ABSSSI each year in the US. This, he said, was based on “the coverage spectrum, IV and oral dosing flexibility, efficacy and safety profile” of the agent.[4]

According to Melinta, “the 450 mg tablet is bioequivalent (area under the curve) to, and interchangeable with the 300 mg IV dose, and can be dosed without regard to food.” [4] These facts will greatly aid the dosing flexibility: they will enable physicians to switch routes of administration when appropriate and may appeal to patients as it provides a less invasive form of therapy.

Delafloxacin is also under phase III development for the treatment of community-acquired bacterial pneumonia in various countries globally.[2]

A black box warning is included in the prescribing information for delafloxacin.[3] It warns that fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together. These include tendinitis and tendon rupture, peripheral neuropathy, and effects on the central nervous system; it is recommended that the drug is discontinued in patients with these adverse events. In addition, it states that delafloxacin should be avoided in patients with a known history of myasthenia gravis.

For further information related to the first approval of delafloxacin please visit Drugs[1] or to learn more about the overall development of delafloxacin across all indications visit AdisInsight.[2]

Image source:  Okea / iStock / Thinkstock

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