Drug company wants to expand use of pneumonia medication

Updated: 12:03 a.m. ET Sept 11, 2006

WASHINGTON - An antibiotic proposed as a treatment for acute sinus infections should be studied further because of serious skin reactions associated with its use, federal health officials said in documents released Monday.

When compared with other antibiotics used to treat minor infections, the incident of serious rashes has Food and Drug Administration officials concerned about the safety of the drug, Factive or gemifloxacin. The regulatory agency released the documents ahead of a Tuesday meeting of outside experts asked to consider the drug.

The FDA approved the drug in 2003 to treat pneumonia and acute bronchitis. Its manufacturer, Oscient Pharmaceuticals Corp., is seeking expanded approval to treat acute bacterial sinusitis as well. In 2002, the FDA had declined to approve that use.

Real-world use of Factive has shown what clinical trials previously revealed: the risk of rashes associated with the antibiotic appears to be greater when compared with that seen in other, similar antibiotics, according to the FDA documents.

In the documents, Oscient said its drug "represents an important additional therapeutic option for treatment" of acute bacterial sinusitis. Factive offers clear benefits and has a safety profile equivalent to other antibiotics. Oscient said.

At Tuesday's meeting, the FDA will ask members of its anti-infective drugs advisory committee whether the benefits of Factive outweigh its risks as a treatment for acute sinusitis. The FDA isn't required to follow the advice of its outside panels of experts, but usually does.

If the panel fails to endorse the drug, the FDA will ask whether further study could support the expanded use of the drug.

FDA briefing documents show that some within the agency already think more study is needed, given the risk of skin reactions associated with the drug: "The magnitude of the benefit gained from the use of gemifloxacin for the indication under discussion (acute bacterial sinusitis) needs to be clearly defined to weigh the magnitude of this drug-related risk," FDA medical officer Dr. Andrew Mosholder wrote in a Sept. 5 memo released Monday.

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The Daily Telegraph, December 18th 2000 (London)

SMITHKLINE Beecham, the drug company, has failed to secure approval for one of its leading drug prospects, just days before it is expected to seal its long-awaited £115 billion merger with Glaxo Wellcome.

Analysts had predicted SmithKline's Factive antibiotic could achieve sales of £350m by 2005. However, the failure to secure approval could delay the drug's arrival on the market by a year - or force the company to abandon its release altogether. Factive was developed to treat respiratory illnesses such as chronic cases of pneumonia, sinusitus and bronchitis.

While the drug is more effective than some of its counterparts, Factive is believed to have some side-effects such as severe rashes and toxicity.

Factive also belongs to a class of antibiotics called Quinolones which may transform human cells, possibly making them cancerous.

Glaxo Wellcome and Warner Lambert both withdrew Quinolones after they caused liver and heart problems among users. This weekend the US Food and Drug Administration issued a non-approval letter - almost a year after the drug was submitted for approval. Yesterday SmithKline said it will now work with the FDA to secure approval. This could involve additional steps including "further discussions of the clinical data to the initiation of additional trials". David Stout, president of pharmaceuticals, said: "We are disappointed about the FDA's decision. However, we continue to believe Factive will be an important contribution to our current treatments and will enhance our anti-infective franchise." A SmithKline spokeswoman said the non-approval will have no effect on the impending merger with Glaxo Wellcome. Factive was discovered by Korean-based LG Chemicals, but SmithKline acquired the worldwide distribution and development rights in 1997. LG retains the marketing rights in some Asian countries.

By Benjamin Wootliff