FDA panel suggests approval of two antibiotics for skin infections

There could soon be new antibiotics to treat acute skin and skin structure infections on the market after a Food and Drug Administration (FDA) advisory committee recommended approval of two new antibiotics March 31.

The committee unanimously supported approval of dalbavancin (Dalvance, Durata Therapeutics) and tedizolid phosphate (Sivextro, Cubist Pharmaceuticals). Dalbavancin is a lipoglycopeptide antibacterial given by injection, and it works by weakening the cell walls of Gram-positive pathogens. Tedizolid phosphate can be taken orally or by injection, and it is a protein synthesis inhibitor that targets Gram-positive organisms.

“Compared to other marked glycopeptide antibacterials, and most other parenteral antibiotics in general, dalbavancin offers a convenient treatment regimen that allows for shortened hospital stays or fully-outpatient treatment, with less risks and discomfort associated with daily multiple infusions of other glycopeptide antibacterial agents with half-lives measured in hours, as opposed to days,” according to the briefing document presented to the FDA Anti-Infective Drugs Advisory Committee.

The document indicates that dalbavancin for injection would treat adult patients with acute bacterial skin and skin structure infections (ABSSSI) as caused by susceptible strains of the following Gram-positive microorganisms:

• Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains);

• Streptococcus pyogenes;

• Streptococcus agalactiae;

• Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).

If approved by the FDA, tedizolid would be one of a handful of antimicrobial agents for the treatment of acute bacterial skin and skin structure infections (ABSSSI) that can be administered intravenously or orally, according to a briefing document presented to the advisory committee.

“If approved, tedizolid phosphate would be a viable alternative to linezolid as effective agent with an established safety profile and a distinct advantage of once daily use for a six-day course of therapy in all adult and adolescent patients with ABSSSI,” the document stated.

The FDA does not have to adhere to advisory committee suggestions, but it often does.