FDA Approves Actavis’ Antibacterial Drug Avycaz

The US Food and Drug Administration (FDA) has approved Actavis’ Avycaz (ceftazidime-avibactam), a new antibacterial drug product. Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor. The drug was approved to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.Avycaz will be available in the second quarter of 2015.

Avycaz is the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP). This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of its QIDP designation, Avycaz was given priority review, which provides an expedited review of the drug's application. The QIDP designation also qualifies Avycaz for an additional five years of marketing exclusivity to be added to the five-year exclusivity period provided by the Food, Drug, and Cosmetic Act.

In 2014, the FDA approved four QIDP-designated antibacterial drugs: Durata Therapeutics' Dalvance (dalbavancin) in May 2014; Cubist Pharmaceuticals' Sivextro (tedizolid phosphate) in June 2014; Cubist Pharmaceuticals Zerbaxa (ceftolozane/tazabactam) in December 2014; and The Medicines Company's Orbactiv (oritavancin) in August 2014. Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria such as Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. Actavis acquired Durata Therapeutics in 2014, and in December 2014, Merck & Co. agreed to acquire Cubist for $9.5 billion. Sivextro and Orbactiv are also approved to treat patients with ABSSSI caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Zebrexa is indicated to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.

Also, Actavis reported this week that it received marketing authorization for Xydalba (dalbavancin) in the European Union for treating ABSSSI. Xydalba is a only once-weekly IV antibiotic approved for a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. Through a license and supply agreement with Angelini, a pharmaceutical company, the drug will be commercialized in 36 countries, which include Italy, Spain, Poland, Portugal, many Eastern European countries, Russia, Turkey, and the Commonwealth of Independent States. The European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in December2014 and is applicable to all 28 member states and the three European Economic Area countries not member states of the European Union. .

Xydalba is a semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. It is approved in the US under the the trade name Dalvance.

Source: FDA , Actavis (Avycaz), and Actavis (Xydalba)

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