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FDA fast-tracks new AstraZeneca antibiotic

Speeds up review period for AZD0914 in gonorrhoea
AstraZeneca AZ headquarters London UK

A new antibiotic from AstraZeneca is set to undergo a shortened review period in the US after receiving Fast Track status from the FDA.

AZD0914 has shown promise as a treatment for the sexually transmitted infection (STI) uncomplicated gonorrhoea, which, like other infectious diseases, is growing increasingly resistant to existing antibiotics.

The Fast Track designation is reserved for drugs to treat serious conditions for which there are currently no, or few, treatment options. It is intended to grant the drug's developer more frequent interaction with the FDA in order for new medicines to reach market faster.

AZD0914 is also classed as a Qualified Infectious Disease Product (QIDP) under changes initiated by the FDA as part of the US Generating Antibiotic Incentives Now (GAIN) Act in 2012.

This status was introduced by the FDA to support research in infectious diseases and grants priority review to new drugs as well as an extension of statutory exclusivity periods once they reach market.

The need for new antibiotics is a worldwide public health problem, with many infectious diseases developing immunity to current treatments. Gonorrhoea is no different, and the World Health Organization (WHO) has warned against the threat of resistance for a disease that accounts for 88 million of about 448 million cases of curable STIs each year.

The US Centers for Disease Control has also designated Neisseria gonorrhoeae - the bacteria that causes gonorrhoea - an immediate public health threat that requires action,

The threat of antibiotic resistance has been exacerbated in recent years by a lack of new treatments, due in part to unfavourable market conditions putting companies off investing in research.

However, in the past few years there has been a renewed urgency to tackle the issue, including a research collaboration between companies involved in the Innovative Medicines Initiative (IMI) and moves in the UK, where AZ is headquartered, to make the research environment favourable for pharma.

AZ is one of the few companies still committed to research in the area and, as well as being involved in the IMI collaboration, is working with researchers in Singapore to discover new antibiotics.

Commenting on the company's work in infectious diseases Manos Perros, VP and head of infection innovative medicines at AZ, said: “There is a critical medical need for new antibiotics to respond to the growing threat of bacterial drug resistance and we have a promising pipeline of early and late-stage anti-infectives.” 

Article by
Thomas Meek

3rd June 2014

From: Sales, Regulatory



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