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Delafloxacin

Fluorochinolonico (FQ) anionico in ABSSSI

ANTI-INFECTIVE

Current development phase: preregistration

preclinical
phase i
phase ii
phase iii
preregistration

Delafloxacin is an anionic fluoroquinolone (FQ), with a good safety profile, active against both Gram positive and negative bacteria, including Methicillin-resistant Staph. aurues (MRSA) and FQs resistant strains. Its balanced and potent activity against both DNA gyrase and topoisomerase IV could help to reduce the selection of resistant strains. 
Both IV and oral formulations are available, enabling an early hospital discharge.


Delafloxacin would be an option for patients with comorbidities, more at risk to be infected with difficult-to-treat pathogens, like MRSA and multi resistant Gram negative strains, leading to recurrent infections, poor patient outcomes and higher use of healthcare resources.

On March 2017 the Menarini Group and Melinta entered into a co-development and commercial agreement in 68 Countries for Delafloxacin. Menarini will be responsible for the regulatory activities, including launch and commercialization of Delafloxacin, in the countries covered by the agreement.
A marketing authorization application for the initial indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is expected to be submitted to EMA in the first quarter (Q1) of 2018. A phase IIIb clinical trial supporting a successful market access in Europe for ABSSSI would start in Q3 2018. A global phase 3 clinical trial in patients with Community Acquired Bacterial Pneumonia  (CABP) is ongoing.

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Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

ABSSSIs are a common cause of morbidity at hospital level and include patients with cellulitis/erysipelas, wound infection, and major cutaneous abscess with a lesion size area of at least 75 cm2. 
In 2012, 2,1mln diagnosed incident cases of ABSSSIs occurred in US, Japan, and five major EU markets. By 2030, the number of patients hospitalized with ABSSSIs in these Countries is expected to increase by 28%. 
Patients with comorbidities, such as diabetes, cardiovascular disease, peripheral vascular disease and obesity, are more at risk to be infected with difficult-to-treat microorganisms, like MRSA* and multi resistant Gram negative strains, leading to recurrent infections, poor patient outcomes and higher use of healthcare resources

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