AstraZeneca Submits sNDA for MERREM(reg) I.V. (meropenem for injection) for Complicated Skin and Skin Structure Infections

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 04 Aug 2004 - 10:00 PDT


AstraZeneca Pharmaceuticals LP has announced that it has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for its antibiotic, MERREM(reg) I.V. (meropenem for injection), to treat patients with complicated skin and skin structure infections. MERREM is currently indicated in the United States as a single agent therapy for the treatment of intra-abdominal infections and bacterial meningitis.

The sNDA submission is based on results from an international, Phase III, randomized, double-blind, multicenter clinical trial of 1,076 patients with a range of complicated skin and skin structure infections as well as a clinical pharmacokinetic study. "Complicated skin infections are a common problem and frequently involve multiple pathogens, making therapy with a broad-spectrum antibiotic like MERREM an important treatment intervention," said David Melnick, MD, Senior Medical Director, Infection, at AstraZeneca.

About Complicated Skin and Skin Structure Infection

Complicated skin and skin structure infections are those involving deep wounds, such as surgical incisions, bites and lacerations, major abscesses, and infected skin ulcers. These include: complicated cellulitis, complex abscesses requiring surgical drainage, perirectal abscesses, surgical and traumatic wound infections, infected diabetic and vascular ischemic ulcers and other skin and skin structure infections requiring surgery or I.V. antibiotic therapy.

About MERREM(reg)

MERREM is a broad-spectrum carbapenem injectable antibiotic indicated for the treatment of intra-abdominal infections in adults and bacterial meningitis and intra-abdominal infections, in pediatric patients three months and older. MERREM is active against various strains of susceptible organisms and can be administered by intravenous infusion or intravenous bolus injection. MERREM is generally well tolerated at high doses and has a low incidence of adverse events. Systemic adverse events reported with MERREM are typical of those seen with other intravenous antibiotics and include diarrhea, nausea, vomiting, and headache. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy beta-lactamase.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

Media contacts

Cindy Callaghan
AstraZeneca Media Inquiries
(302) 886-2959
Sandra Heinig
AstraZeneca
(USA) (302) 885-1084

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