רוקחות-פרמקולוגיה

FDA panel backs two GlaxoSmithKline drugs for COPD

By Peter Ramjug

GAITHERSBURG, MD (Reuters) – A US advisory panel on Thursday backed GlaxoSmithKline Plc's Flovent and Advair to treat chronic obstructive pulmonary disease (COPD), a lung condition marked by blocked airways and the fourth leading cause of death in the United States.

The US Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee, comprised of outside experts, recommended the drugs for long-term, twice-daily maintenance for COPD, an umbrella term to describe emphysema and chronic bronchitis that decreases air flow in and out of the lungs.

Flovent and Advair are already on the market as an asthma treatment.

Several members of the committee expressed reservations about the long-term safety and efficacy of the drugs and said that more studies and stringent labeling were needed.

"There are certain potential side effects that will be perhaps more apparent with longer-term follow up," said committee Chairman Mark Dykewicz, a professor at the St. Louis University School of Medicine.

The vote on Flovent was 5-4 in favor, while the panelists backed Advair 6-2. Each carried one abstention.

The ultimate decision for approval rests in the hands of the FDA, which usually follows its panels' advice.

"Clearly we're pleased" about the outcome, said Glaxo spokeswoman Lisa Behrens. "We think that both therapies have an important role in the management of COPD."

No inhaled corticosteroid, including Flovent, is currently approved for COPD in the United States. The drug, however, is approved in 67 other countries as of the end of August, according to a Glaxo doctor at the meeting.

Advair is currently not approved for COPD in any country.

COPD affects an estimated 21.7 million Americans and is currently the fourth leading killer in the United States, and could become the number three cause of death by 2020, said David Wheadon, a senior vice president at Glaxo.

"The burden of this disease on society is enormous," he said at the meeting. "In 1997, direct and indirect costs associated with COPD were estimated to be over $30 billion in the US alone, and it is likely that these costs will continue to increase."

COPD is most frequently caused by smoking, but secondhand smoke and air pollution can also be factors. Patients in Glaxo's studies were largely white men in their 60s. There is no cure for COPD.

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