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FDA reviewers support Optimer antibiotic

Reviewers from the US Food and Drug Administration have issued a positive memo on Optimer Pharmaceuticals' C. difficile treatment fidaxomicin ahead of an advisory committee meeting

Staff reviewers from the US Food and Drug Administration (FDA) have issued a positive memo on Optimer Pharmaceuticals' orally delivered antibiotic fidaxomicin in anticipation of an advisory committee meeting on the drug that is scheduled to take place on Tuesday.

The FDA reviewers said the company's data support the drug's efficacy in treating Clostridium difficile infections, which are characterised by diarrhoea and inflammation of the colon. C. difficile is a common hospital-acquired infection and can be life-threatening, especially in older patients.

In the documents, which are intended to help guide the advisory panel members, the FDA staff reviewers said fidaxomicin worked as well as ViroPharma's Vancocin (vancomycin) in curing C. difficile infections and was better than vancomycin at preventing recurrences of infection.

The FDA reviewers also noted, however, that serious adverse events, including gastrointestinal bleeding, were seen somewhat more often in the fidaxomicin patients than in the vancomycin patients.

Currently, vancomycin is the only FDA-approved drug for C. difficile, although metronidazole is used off-label. About 30 per cent of patients who initially respond to these treatments have a clinical recurrence once drug treatment ends, according to Optimer.

Fidaxomicin, which is Optimer's lead product candidate, could have global sales of about $203m a year, according to a consensus analyst forecast complied by Thomson Reuters. Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase.

The FDA is due to take action on the marketing application for the drug, which was awarded a priority review, by May 30.

4th April 2011

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