FDA Says Pfizer Drug Works to Open Airways
WASHINGTON (Reuters) - A new drug to treat a smoking-related disease that is America's No. 4 killer seems effective for opening patients' airways, but its effect on shortness of breath is "less convincing," U.S. Food and Drug Administration staff said in
Pfizer Inc. and marketing partner Boehringer Ingelheim, a privately held German company that developed the drug called Spiriva, are aiming to sell it in the United States to treat chronic obstructive pulmonary disease, known as COPD.
The FDA staff report also said safety data "contains subtle suggestions that (Spiriva) may be associated with increased adverse cardiac effects, particularly in the category of 'heart rate and rhythm disorders."'
An FDA advisory panel is scheduled to meet Friday to consider whether to urge U.S. approval for Spiriva, which some analysts have predicted will be a blockbuster product.
The FDA staff report was posted on the agency's Web site. The staff opinion will be considered by the outside experts on the advisory panel before they make recommendations. The FDA has the final say on whether to approve drugs, but the agency usually follows its panels' advice.
Ira Loss, an analyst for Washington Analysis, said he thought the panel would recommend approval for Spiriva but will debate whether the companies can claim the drug improves shortness of breath, known as dyspnea. No other drug for COPD has that indication as an approved use.
"They obviously have shown efficacy for COPD, and dyspnea is one of those things that has never been broken out as a separate situation," Loss said.
Loss said he did not think the possible cardiac effects mentioned by FDA staff were enough to keep the drug off the market. "All of these products that are inhaled to treat this have some cardiac effect," he said.
Boehringer Ingelheim and Pfizer recently launched Spiriva in Europe.
COPD is a persistent blockage of the airways, typically caused by a combination of emphysema -- destruction of the walls of air sacs in the lungs -- and chronic bronchitis, a cough that produces sputum.
Spiriva, a once-a-day inhaled treatment, helps open the airways by blocking action of the brain messenger chemical acetylcholine. Some doctors have said they expect Spiriva to become the new first-choice treatment for COPD.
Ninety percent of COPD cases are among smokers, although only about 20 percent of smokers actually develop the disease.
People with COPD usually smoke for decades, until their mid-50s, before symptoms show up. But by then, they typically have lost up to 70 percent of their lung function and begin having worsening shortness of breath and ability to exercise.