Type of information: Submission of a Market Application in the EU
Product name: Baxdela® (US)/Quofenix®(UE)
Therapeutic area: Infectious diseases
- antibiotic. Delafloxacin is an anionic fluoroquinolone antibiotic currently in Phase 3 clinical development for hospital-treated skin infections, known as acute bacterial skin and skin structure infections (ABSSSI). In clinical trials, delafloxacin is being tested in both IV and oral formulations.
- Under a 2017 agreement, Menarini has exclusive rights to commercialize delafloxacin (marketed as Baxdela™ in the U.S.) in 68 countries in Europe, Asia-Pacific including China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia. This submission represents the first application by Menarini for regulatory approval in their territory.
Company: Melinta Therapeutics (USA - CT)
- acute bacterial skin and skin structure infections (ABSSSI)
- • On March 8, 2018, Melinta Therapeutics announced that The Menarini Group, Melinta’s commercial and co-development partner, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for delafloxacin (to be marketed under the trade name Quofenix® in Europe) for the treatment of adult patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI). This MAA is based on results of the two Phase 3 PROCEED studies (NCT01811732 and NCT01984684), which met both FDA- and EMA-specified primary endpoints.
- • On June 19, 2017, Melinta Therapeutics announced that the FDA has approved Baxdela™ (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria.
- The Baxdela New Drug Application (NDA) approvals were supported by two Phase 3 studies in patients with ABSSSI, demonstrating that IV and oral Baxdela™ monotherapy was statistically non-inferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48-72 hours. Baxdela was well tolerated with a 0.9% discontinuation rate in the Phase 3 studies due to adverse events. In addition, Baxdela has not shown any potential for QT prolongation or phototoxicity in definitive clinical studies. There have been no signals of adverse effects on liver function, kidney function, or glucose regulation in controlled clinical studies. 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. There are no anticipated drug-drug interactions with delafloxacin other than co-administration with chelating agents, such as antacids.
- • On February 27, 2017, Melinta Therapeutics announced that the FDA has informed the company, as part of its mid-cycle review process, that it does not currently plan to hold an Advisory Committee meeting for Melinta’s New Drug Applications (NDAs) for Baxdela™ (delafloxacin).
- • On January 5, 2017, Melinta Therapeutics announced that the FDA has accepted its New Drug Applications (NDAs) for IV and oral Baxdela™ (delafloxacin) for filing and granted Priority Review status to both NDAs. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of June 19, 2017.
- • On October 24, 2016, Melinta Therapeutics announced that it has submitted New Drug Applications (NDAs) to the FDA for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Melinta’s NDAs are based on the results of two Phase 3 studies (NCT01811732 and NCT01984684), in both of which Baxdela met the primary endpoint 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.
- Baxdela has been designated a Qualified Infectious Disease Product (QIDP) by the FDA, which provides for priority review.
Submission of marketing authorization application USA : 2016-10-14
Submission of marketing authorization application UE: 2018-03-08
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-06-19
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: