FDA granted priority for assessment of new drugs increases cyclophilin status - antibiotics, new drugs - the pharmaceutical industry

FDA granted priority for assessment of new drugs increases cyclophilin status - antibiotics

, new drugs - the pharmaceutical industry

Wyeth Research for intravenous use Antibiotic Pharmacokinetics of cyclophilin TygacilTM (tigecycline) for new drug application priority review status. Be given priority status of new drugs means that the product, if the applicant once approved, than existing treatment methods have improved significantly.

Tygacil is approved for registration as glycyl-class (a new class of antibiotics), the first variety. It can overcome many restrictions on the use of antibiotics resistance in the two main mechanisms: efflux pumps and ribosomal protection.

"Given the complexity of infection, especially resistance to existing antibiotics, the number of infections are on the rise, now almost no new antibiotics under development, while the demand for new types of treatment but is very urgent," Hui s president of research and development, said Dr. RobertRuffolo, "Tygacil a very broad-spectrum antibiotics, can help clinicians to deal drugs during a single empirical treatment produced some of the challenges of bacterial resistance."

Wyeth is trying to seek the approval of the market, so Tygacil to the following diseases as a single drug treatment means: by the gram-negative and positive bacteria, anaerobes, and methicillin-resistant Staphylococcus Staphylococcus (M RS A) and methicillin-sensitive Staphylococcus aureus (MSSA) caused complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI). Tygacil new drug application submissions, including four crucial phase III clinical trial data, testing the product in the treatment of cIAI and cSSSI Security And efficacy data, including the anti-Gram-negative and gram-positive bacteria, anaerobes, and certain resistant pathogens in vitro test data.

"Medical profession has been working tirelessly to find the treatment of severe infections and new ways to improve patient care," Northwestern University Feinberg School of Medicine Department of Medicine Infectious disease Laboratory of GaryNoskin Dr. said, "Unfortunately, many broad-spectrum antibiotics are losing effectiveness."

2004 12 15, new drug application to the United States, while Wyeth has submitted to the European Medicines Agency, a marketing authorization application (MAA), as well as regulatory authorities of Switzerland to Australia and other relevant documents submitted. This is the first time Wyeth also apply for a new product approved by U.S. and international. New drug application submitted to the FDA documents were approved in the United States an important step. FDA sets new drug application submitted in completed within six months from the date of priority review of the objectives (including the approval of the decision).

Treatment of severe Hospital Infection More and more patients from the community to the hospital showed bacterial resistance, and in the past only happened in the hospital setting. Since almost no broad-spectrum antibiotic currently under development to counter the existing and still continue to generate resistance to bacteria, Ershi the problem worse. According to recently published in the medical journal "Clinical resistance to infectious diseases" (Clinical InfectiousDiseases) an article, the 15 largest in the world Pharmacy 31 companies in the anti-infective research and development, only five kinds of antibiotics.

In the United States alone in patients with nosocomial infection had two million per year, about 90,000 people dead. About 70% of these infections at least one drug resistance. Resistance to antibiotics leading to increased morbidity and mortality, and American society is at least a year from 4000 to 5000 million U.S. dollars in medical expenses.

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