Gilead Seeking FDA Panel Backing Of Inhaled Antibiotic

Gilead Sciences Inc. (GILD) is hoping a federal advisory panel will prod the Food and Drug Administration to reverse a decision involving a proposed inhaled-antibiotic designed to treat a stubborn lung infection in cystic fibrosis patients.

Last year the FDA refused to approve the drug, inhaled aztreonam, saying the clinical evidence was insufficient to show whether the product was effective. Gilead has proposed a brand name of Cayston for the drug. Aztreonam was originally approved in 1986 as an intravenous or IV drug and is also available as an injection.

One of the main clinical studies showed that Cayston was effective when given three-times a day when compared to patients receiving a placebo, or fake drug, but when given twice daily, the drug was no better than the placebo. All patients in that study were also previously treated with another inhaled antibiotic. Gilead is seeking FDA approval for Cayston as a three-times daily inhaled treatment.

Gilead said, in a document posted to the FDA's Web site Tuesday, that it filed a dispute resolution with the agency involving the issuance of the so-called complete response letter, which was dated Sept. 16, 2008.

The complete response letter outlined why the agency wasn't approving the product. Gilead said its dispute resolution was denied in February, so the firm submitted a higher-level appeal with the agency's Office of New Drugs and included additional analyses of one of the clinical studies in question.

While the Office of New Drugs also denied the company's appeal, the office said the company could submit the additional analysis and request an advisory committee meeting. The agency's anti-infectives drugs advisory committee will consider Cayston Thursday.

The panel is made up of outside medical experts who are being asked to vote on whether Gilead has provided "substantial" evidence of the effectiveness and safety of the inhaled antibiotic. The FDA usually follows its panel's advice but is not required to do so.

Specifically, Gilead is seeking FDA approval of Cayston to treat a bacterial lung infection known as Pseudomonas aeruginosa or PA in patients with cystic fibrosis, an inherited disease that affects the lungs and digestive system. The disease, which is believed to affect about 30,000 Americans, causes mucus to build up in the lungs and digestive tract. Lung infections are common.

The FDA said, in a document prepared for Thursday's meeting, that Gilead's re-analyses of the study involving the twice-daily and three-times daily dosing, "could not be shown to be robust under varying conditions." The agency also said patients receiving Cayston three-times daily had higher hospitalization rates than those in the placebo group.

Gilead said the totality of the Cayston dataset, which involves two Phase 3 studies required for FDA approval, along with an extension study, "supports a favorable risk-benefit assessment."

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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