« Back

FDA reviewers support efficacy of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections

Thursday, September 02 2010 | Comments

---

What's This? Food and Drug Administration reviewers support the efficacy claims outlined by Cerexa Inc. in a New Drug Application (NDA) for ceftaroline fosamil, a broad-spectrum, intravenous (IV), next-generation cephalosporin antibiotic being reviewed as a treatment for community-acquired bacterial pneumonia (CABP) and complicated skin and skin structure infections (cSSSIs).

Cerexa, a subsidiary of Forest Laboratories Inc., submitted the NDA covering the two indications in December. The filing included data from two Phase III CABP trials that compared ceftaroline with ceftriaxone sodium in adults requiring IV antimicrobial therapy in an acute care setting and two Phase III cSSSI trials that compared the agent with vancomycin hydrochloride plus aztreonam in adults also requiring treatment in an acute care setting.

In documents posted on the FDA's website ahead of the Sept. 7 meeting of the agency's Anti-Infective Drugs Advisory Committee, the FDA reviewers concluded that for the CABP indication, the studies met their prespecified endpoints of demonstrating a clinical response at the test-of-cure visit, even after performing a sensitivity analysis that included only the study participants with confirmed baseline CABP pathogens.

For the cSSSI indication, both studies had a primary objective of determining the noninferiority of ceftaroline relative to vancomycin plus aztreonam in adults with cSSSI based on the difference in clinical cure rates at the test-of-cure visit. The reviewers said the data supported the noninferiority claim of ceftaroline, even after they performed sensitivity analyses.

Overall, the safety profile for ceftaroline was similar to that observed with the active comparators.

In separate documents posted on the FDA's website, Forest said the efficacy and safety data support a positive benefit-to-risk profile for the agent, which is active against gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus, multidrug-resistant Streptococcus pneumoniae and penicillin-resistant S. pneumoniae.

The antimicrobial is projected to attain almost $361 million in sales in 2014 if approved, according to Thomson Reuters forecasts, Reuters reported.

Forest obtained the rights to ceftaroline in countries other than Japan when it acquired Cerexa in 2006.

Print  |  E-mail