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Date: 2014-10-08

Type of information: Granting of a Fast Track status

Product name: lefamulin (BC 3781)

Compound: acetic acid, 2-(((1R,2R,4R)-4-amino-2-hydroxycyclohexyl)thio)-, (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyldecahydro-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-3a,9-propano-3ah-cyclopentacycloocten-8-yl ester)

Therapeutic area: Infectious diseases

Action mechanism:

antibioctic/pleuromulin derivative. Lefamulin (BC 3781) belongs to the first generation of pleuromutilins to combine excellent systemic bioavailability with substantial activity against Gram-positive pathogens, and fastidious Gram-negative pathogens plus atypical pathogens. Pleuromutilins interfere with bacterial protein synthesis via a specific interaction with the 23S rRNA of the 50S bacterial ribosome subunit. These antibacterials have a distinct anti-bacterial profile. Their unique mechanism of action implies a very low probability of cross resistance with other antibacterials. In an industry first, Nabriva\'s world class medicinal chemistry expertise achieved the development of intravenous and orally available pleuromutilins clearing the way for i.v. and oral therapy with this antibiotic class. This achievement constitutes a significant milestone in providing appropriate medication for the treatment of life-threatening bacterial infections offering a distinctly different class of antibiotics for the treatment of bacterial diseases.

Lefamulin is highly active against multi-drug resistant (MDR) pathogens including Methicillin resistant Staphylococcus aureus (MRSA), MDRStreptococcus pneumoniae, Vancomycin resistant Enterococcus faecium.

 

Company: Nabriva Therapeutics (Austria)

Disease:

community-acquired bacterial pneumonia (CABP)

acute bacterial skin and skin structure infections (ABSSSI)

Latest news:

* On October 8, 2014, Nabriva Therapeutics, a biotechnology company focused on developing pleuromutilins, a new class of antibiotics for the treatment of serious infections caused by resistant Gram-positive and Gram-negative pathogens, announced that the FDA has granted Qualified Infectious Disease Product (QIDP) as well as Fast Track status designation to Nabriva’s lead product lefamulin, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

The FDA’s Fast Track program allows an expedited review facilitating the development of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The QIDP designation allows five extra years of market exclusivity for antimicrobials designed to treat serious and life-threatening infections. These designations have been granted to lefamulin used for the treatment of CABP and ABSSSI. It is estimated that five to 10 million cases of CABP in the US lead to 1.1 million hospitalizations and 45,000 deaths annually. ABSSSI are among the most common infections requiring hospitalization and exert a substantial burden on the health care system.

Dr Colin Broom, Chief Executive Officer of Nabriva, commented on the news: “The FDA’s QIDP and Fast Track designations are validation of Nabriva’s approach and underlying science to develop a truly novel antibiotic product able to address significant unmet need. Nabriva is establishing its US office and clinical development team in Philadelphia and is focussed on advancing lefamulin to phase 3 trials, for an initial indication in CABP.”

Patents:

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Withdrawal of marketing authorization application USA:

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Is general: Yes