FDA Grants Antibiotic Tygacil(TM) NDA Priority Review Status

Main Category: MRSA / Drug Resistance
Article Date: 30 Jan 2005 - 9:00 PDT

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Tygacil is the first in a new class of antibiotics called glycylcyclines to be submitted for regulatory approval - It was designed to circumvent two major resistance mechanisms that have limited the use of many antibiotics: efflux pumps and ribosomal protection.

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the US Food and Drug Administration (FDA) granted priority review status to the company's New Drug Application (NDA) for the investigational I.V. antibiotic Tygacil(TM) (tigecycline). A priority designation can be given to an NDA for a drug that, if approved, would be a significant improvement compared with existing treatments.

"While the number of complicated infections, particularly those resistant to available antibiotics, is on the rise, few antibacterial agents are known to be in development, and there is an urgent need for new treatment options," says Dr. Robert Ruffolo, President of Wyeth Research. "Tygacil, an expanded broad-spectrum agent, has the potential to help clinicians overcome challenges associated with certain bacterial resistance when selecting an empiric monotherapy."

Wyeth is seeking market approval for Tygacil as a single agent therapy to treat patients with complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI), caused by gram- negative and gram-positive pathogens, anaerobes, and both methicillin- susceptible and methicillin-resistant strains of Staphylococcus aureus (MSSA and MRSA). The Tygacil NDA submission included data from four pivotal phase III studies examining the safety and efficacy of Tygacil for the treatment of cIAI and cSSSI. The submission also included in vitro data against both gram- negative and gram-positive bacteria, anaerobes, and certain drug-resistant pathogens.

"The medical community is constantly looking for new ways to treat serious infections and improve patient outcomes," says Dr. Gary Noskin, Department of Medicine and Division of Infectious Diseases, Feinberg School of Medicine at Northwestern University. "Unfortunately, many antibiotics which are used against a broad range of bacteria are now losing effectiveness."

Concurrent with its NDA submission in the U.S., Wyeth also submitted a Marketing Authorization Application (MAA) with the European Medicines Agency and additional filings with authorities in Australia and Switzerland on December 15, 2004. This was the first time Wyeth applied simultaneously for U.S. and global approval of a new product. Filing of the NDA with the FDA is an important step in the approval process in the U.S. The FDA sets a goal for completing priority reviews (including judgment on approval) at six months after the NDA submission date.

Treating Serious Infections in Hospitals

More and more patients admitted to hospitals from the community are presenting with antibiotic-resistant bacteria that were previously only found within the hospital environment. This issue is compounded by the fact that few broad-spectrum antibiotic agents are currently in development to fight existing and emerging resistant bacteria. According to an article recently published in the medical journal Clinical Infectious Diseases, just five of 31 anti-infectives in development at the world's 15 largest pharmaceutical companies are antibacterial agents.

In the U.S., hospital-acquired infections alone afflict approximately 2 million patients and kill nearly 90,000 people annually. About 70 percent of these infections are resistant to at least one drug. Antibiotic resistance leads to increased mortality and morbidity and generates a minimum of $4 billion to $5 billion in costs to U.S. society annually.

About Wyeth

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of infectious diseases, women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade-buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission.

Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

http://www.wyeth.com

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