FDA Approves Genesoft's Factive for Multi-Drug Resistant S. Pneumoniae Indication


SOUTH SAN FRANCISCO, Calif. -- Genesoft Pharmaceuticals Inc. announced today that the United States Food and Drug Administration (FDA) approved its new drug application efficacy supplement for Factive (gemifloxacin mesylate) to treat mild-to-moderate community- acquired pneumonia (CAP) due to multi-drug resistant Streptococcus pneumoniae (MDRSP). Factive is the first antibiotic specifically indicated for CAP caused by these resistant organisms.

In light of the increasing rate of cross-resistance among bacteria to many current antibiotics, approval of Factive for this new MDRSP indication gives physicians an important option for the treatment of pneumonia, especially when drug-resistant strains are suspected. In April 2003, Factive received FDA approval for the treatment of mild-to-moderate CAP caused by other pathogens and for acute bacterial exacerbations of chronic bronchitis (ABECB).

Antibiotic resistance occurs when bacteria change in a way that reduces or eliminates the efficacy of antibiotics designed to treat the infection. Though antibiotics are effective in treating bacterial infections, they are not effective against viral infections, such as the common cold or influenza. The improper use of antibiotics -- such as to try treating a viral infection -- leads to the development of resistant or mutant bacteria, which will no longer respond to available therapies.

"The increase in resistance to numerous antibiotic classes poses a problem for the physician in empirically selecting the correct antibiotic," said Gary Patou, MD, president of Genesoft. "Bacterial resistance is a very real and emerging problem. Increasingly, physicians are realizing that their prescribing decisions can not only affect the individual patient receiving a drug, but can also have a larger societal impact. Approval of a specific claim for Factive to treat MDRSP provides physicians with a powerful and effective antibiotic option for patients."

Pneumonia is the leading cause of death due to infections, and as many as 4 million cases of CAP are diagnosed each year. Over one-fourth of S. pneumoniae isolates in the United States are currently multi-drug resistant according to recent surveillance data.(i) Multi-drug resistant S. pneumoniae is defined as strains resistant to two or more of the following antibiotics: penicillin, second generation cephalosporins such as cefuroxime, macrolides such as clarithromycin (Biaxin(R))(ii) or azithromycin (Zithromax(R)),(iii) tetracyclines and trimethoprim/sulfamethoxazole.

Factive (gemifloxacin mesylate) is an orally administered, broad-spectrum fluoroquinolone antibiotic to which Genesoft owns all North American and European rights. Factive was approved for sale in the United States in April 2003. Factive should only be used to treat infections that are proven or strongly suspected to be caused by bacteria. It does not treat viral infections. The most common side effects include diarrhea, rash, nausea and headache. Rash is generally mild to moderate in nature, and more likely to occur if taken for longer than the recommended course.


(i) Jacobs, M.R.; Felmingham, D.; Appelbaum, P.C.; Gruneberg, R. N.; the

Alexander Project Group. J. Antimicrob. Chemother., advance access

published July 15, 2003.

(ii) Biaxin is a registered trademark of Abbott Laboratories.

(iii) Zithromax is a registered trademark of Pfizer Inc.

Source: Genesoft Pharmaceuticals Inc.

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