US FDA gives `fast-track’ status for AstraZeneca’s novel antibiotic for treatment of gonorrhea

AstraZeneca has announced that the US Food and Drug Administration (FDA) has designated its novel investigational drug AZD0914 as a qualified infectious disease product (QIDP) and awarded its development programme fast track status for the treatment of uncomplicated gonorrhoea, which is increasingly resistant to existing antibiotics and poses a serious global public health threat.
 
AZD0914 is a novel oral antibiotic entering Phase II clinical trials to investigate efficacy in treating uncomplicated gonorrhoea and is the first of a novel class of molecules to be developed for this indication, the company said.

Uncomplicated gonorrhoea is becoming increasingly difficult to treat as the Neisseria gonorrhoeae bacterium has developed resistance to successive classes of antibiotics.

There are currently few treatment options and the US Centers for Disease Control and prevention has recently designated Neisseria gonorrhoeae an immediate public health threat that requires urgent and aggressive action.

Manos Perros, vice president and head of infection innovative medicines at AstraZeneca, 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. We are pleased the distinctive science behind AZD0914 has been recognised with the FDA's QIDP and fast track designations, which will enable us to deliver this medicine, if approved, more quickly to patients who urgently need new treatments.''

The QIDP designation was created by the US Generating Antibiotic Incentives Now (GAIN) Act, implemented in 2012 to encourage the development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections.

Fast track status is a process designed to facilitate and speed up interactions with the FDA on issues related to study design, safety data, the use of biomarkers and other critical issues in the development and regulatory review of drugs.

The QIDP and fast track designations mean that AZD0914 is eligible for priority review by the FDA and a five-year extension of exclusivity under the US Hatch-Waxman Act if approved.

If untreated, gonorrhoea can lead to serious and permanent health problems, including pelvic inflammatory disease, first-trimester abortions, ectopic pregnancy and infertility. The World Health Organisation (WHO) estimates that in 2012, gonoccocal infections represented 106 million of the estimated 498 million new cases of curable sexually transmitted infections that occur globally every year.

AstraZeneca's antibiotics portfolio include small-molecule assets such as `Merrem' (meropenem) and Zinforo' as well as a strong preclinical and clinical portfolio of investigational agents, including Caz Avi (combination of ceftazidime and avibactam), CXL (ceftaroline plus avibactam), Atm Avi (aztreonam plus avibactam) and AZD0914.