The problem of ineffective antibiotics is no longer just theoretical. These days, nearly 50,000 people in the US and Europe die each year as a result of antibimicrobial-resistant infections. To reduce this grim toll, in 2012 the US Food and Drug Administration (FDA) began offering the qualified infectious disease product (QIDP) designation, which allows for expedited review and five extra years of market exclusivity for antimicrobials designed to treat serious and life-threatening infections.
On 23 May, the FDA approved its first QIDP drug, an antibacterial called Dalvance (dalbavancin) produced by Chicago-based Durata Therapeutics. Dalbavancin was approved to treat acute bacterial skin and skin structure infections (ABSSSI), caused mainly by Staphylococcus or Streptococcus bacteria—both of which are Gram positive and both of which are listed as “serious” threats in the 2013 Antibiotic Resistance Threat Report from the US Centers for Disease Control and Prevention. Two phase 3 trials published on 5 June showed that dalbavancin worked as well as vancomycin, the drug most widely used for Gram-positive skin infections (N. Engl. J. Med. 370, 2169–2179, 2014). Unlike vancomycin, which is given daily, dalbavancin is administered just once a week, which could shorten or prevent hospital stays.
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