FDA Advisory Committee Recommends Approval Of Forest Laboratories' Ceftaroline Fosamil For The Treatment Of Community Acquired Bacterial Pneumonia

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 12 Sep 2010 - 1:00 PDT


Forest Laboratories, Inc. (NYSE: FRX) announced that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted 21 - 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 - 0 in favor of approval for complicated skin and skin structure infections (cSSSI).

Ceftaroline is a novel, bactericidal, broad-spectrum injectable cephalosporin shown in pre-clinical and clinical trials to have activity against both gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae, and common gram-negative pathogens.

The committee's recommendation will be considered by the FDA as it reviews the new drug application (NDA) for ceftaroline, which was based primarily on data from two Phase III trials in CABP FOCUS I and FOCUS II - and two Phase 3 trials in cSSSI - CANVAS I and CANVAS II. Forest anticipates action by the FDA during the fourth calendar quarter.

About Ceftaroline and Ceftaroline / NXL104

Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of cSSSI and CAP, which include resistant gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and S. pneumoniae (as well as common gram-negative organisms). Ceftaroline has demonstrated antibacterial activity in vitro against vancomycin-resistant S. aureus (VRSA) and linezolid-resistant S. aureus. Ceftaroline is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In clinical trials, ceftaroline has been generally well tolerated with an adverse event profile consistent with the cephalosporin class of antibiotics. Forest obtained the worldwide rights (excluding Japan, where Takeda Pharmaceuticals holds rights) to ceftaroline in 2007 when it acquired Cerexa, Inc., a privately held biopharmaceutical company. In August 2009, Forest Laboratories and AstraZeneca (NYSE:AZN) entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline in all markets outside the U.S., Canada and Japan.

Forest is also developing a combination product consisting of ceftaroline and NXL104, a novel beta-lactamase inhibitor. The combination of NXL104 with ceftaroline enhances the in vitro antibacterial activity of ceftaroline against extended-spectrum beta-lactamase-producing (ESBL) gram-negative bacteria that are normally resistant to currently available broad-spectrum cephalosporins.

About CABP Requiring Hospitalization

In 2006, pneumonia, along with influenza, was the eighth leading cause of death in the U.S. and the number one cause of death in those over age 65. The cost of care for patients with CABP in the U.S. has been estimated to be over $10 billion annually.

The primary treatment for CABP is antibiotics, and the rates of resistance to many commonly used antibiotics are increasing. S. pneumoniae accounts for 60 to 70 percent of all bacterial CABP cases and data have shown that, overall, pneumococcal strains had a 28 percent intermediate resistance rate and a 16 percent high-level resistance rate. With increasing rates of pneumonia caused by MRSA and the high rates of resistance to common antibiotics, treatment options are becoming more limited.

About cSSSI

cSSSIs are caused by gram-positive bacteria, such as MRSA, and common gram-negative bacteria. cSSSIs are among the most common infections treated in the hospital setting and MRSA infections are becoming more common in patients in both the hospital and community settings, now the most frequent cause of cSSSI presenting to emergency departments in the United States and the cause of over 18,000 deaths in 2005.

According to the Centers for Disease Control and Prevention, about 70 percent of bacterial infections are resistant to at least one drug. Many are resistant to multiple drugs making cSSSIs, especially due to MRSA, challenging to treat. cSSSIs can become extremely serious, leading to hospitalization, an increased risk for morbidity and mortality and increased healthcare costs.

Source: Forest Laboratories, Inc

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