MRSA 'superbugs' Credit: © The Science Picture Company / Alamy

US Food and Drug Administration (FDA) officials green-lighted a new drug to treat skin infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The approval is the first in a series of next-generation antibiotics coming to market after years of neglected investment in the space. Chicago-based Durata Therapeutics' antibiotic Dalvance (dalbavancin) is a glycopeptide agent, designed as an improved alternative to vancomycin. Dalvance is also the first drug with Qualified Infectious Disease Product designation—which grants an additional five year market exclusivity—to receive agency approval. Another agent for treating skin infections caused by S. aureus or other Gram-positive bacterial pathogens, Cubist's Sivextro (tidezolid), was expected to be approved on June 20 following an earlier unanimous recommendation by the FDA's advisory committee. Sivextro belongs to the oxazolidinones class and will be competing with linezolid (Pfizer's Zyvox), although Sivextro is considered safer and easier to administer, with once-daily instead of the twice-daily oral or intravenous dosing of Zyvox. Meanwhile, Dalvance appears to be curative when dosed twice, a week apart, but with a rather narrow spectrum of activity, mainly against S. aureus. Although both these candidate antibiotics were brought to FDA specifically to treat acute skin and skin structure infections, they are likely to be used more broadly, particularly to deal with antibiotic-resistant infections in other indications. Indeed, a report released late in April by the World Health Organization (WHO), “Antimicrobial resistance: global report on surveillance,” provides a global perspective on this “major threat to public health,” documenting resistance to antibiotics, “especially 'last-resort' antibiotics, in all regions of the world.” Although the WHO report calls for measures that will lower the need for such drugs, it also urges the development of new antibiotics. Industry is taking greater heed of that message. In April, for example, Spero Therapeutics in Cambridge, Massachusetts, forged an alliance with Roche to further its development of an antimicrobial drug that targets Pseudomonas aeruginosa, a Gram-negative bacterial pathogen. Separately, Euprotec in Manchester, UK, in May entered into an alliance with Cantab Anti-infectives near Cambridge, UK, to develop antibiotics to treat multidrug-resistant Gram-negative bacterial infections. On April 30, the European commission approved Otsuka's Deltyba (delamanib) to treat multidrug-resistant tuberculosis.