AstraZenecas Novel Antibiotic Candidate AZD0914 Given Fast Track Status by US FDA
AstraZeneca has announced that the US 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. 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 5-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 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.
Related News
-
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News Eisai Alzheimer’s drug authorised in UK but still faces obstacles
In partnership with BioArctic AB, pharmaceutical company Eisai has been granted Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for its Alzheimer’s disease drug product Leqembi. -
News Eli Lilly's weight loss drugs removed from the FDA's shortage list
The US FDA have recently updated their drug shortage list. The recently released list shows that all dosage forms of Eli Lilly's weight-loss drug Zepbound and their diabetes drug Mounjaro are now available. -
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA).
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance