News Scan for Jun 23, 2014

FDA OKs another antibacterial
H7N9 case in China

FDA approves another antibacterial for skin infections

The US Food and Drug Administration (FDA) has approved tedizolid phosphate (Sivextro), a new antibacterial drug to treat adults with acute bacterial skin and skin structure infections (ABSSSI), the agency announced on Jun 20.

Tedizolid, made by Cubist Pharmaceuticals, Lexington, Mass., is the second antibacterial for skin infections to win FDA approval in the past month. On May 23 the agency approved dalbavancin (Dalavance), made by Durata Therapeutics of Chicago.

The FDA said tedizolid is intended for ABSSSI caused by certain susceptible bacteria, including Staphylococcus aureus (both methicillin-resistant strains [MRSA] and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. It is available for intravenous and oral use.

The drug received an expedited review because it was designated as a qualified infectious disease product, the agency said. That designation also qualifies it for an extra 5 years of marketing exclusivity, on top of exclusivity periods already provided by the Food, Drug and Cosmetic Act.

The Infectious Diseases Society of America (IDSA) said the approvals of tedizolid and dalbavancin signify progress in the group's 10 x '20 Initiative, which aims for the development of 10 new antibiotics by 2020.

In an e-mailed statement, IDSA President Barbara Murray, MD, said that since the launch of the initiative in 2010, three antibiotics have been approved, and pharmaceutical manufacturer Roche has announced plans to invest in the development of new antibiotics.

"While this news is encouraging, we still have a great deal more work to do to combat antibiotic resistance and ensure we have the tools necessary to help the patients who need it the most," Murray said.
Jun 20 FDA announcement
Jun 5 CIDRAP News item on dalbavancin


China reports new H7N9 case in Zhejiang province

A 51-year-old man from Taizhou, a city in Zhejiang province, is in critical condition after contracting H7N9 avian influenza, according to a Macao health bureau report translated and posted today by the infectious disease news board FluTrackers.

The man, a market greengrocer, was hospitalized on Jun 20, the report said.

His case pushes China's overall H7N9 outbreak total to 451, according to an ongoing tally kept by FluTrackers. The number of outbreak deaths remains at at least 158.
Jun 23 FluTrackers thread
FluTrackers human H7N9 case list

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