Pharma

Does FDA’s approval of first obesity drug in 13 years reflect a policy shift?

The U.S. Food and Drug Administration’s move to approve the first obesity drug in 13 years seems to reflect a calculated risk by the regulator that the health hazards associated with weight loss drugs are eclipsed by the urgency of escalating medical costs associated with widespread obesity in the country. The healthcare costs associated with […]

The U.S. Food and Drug Administration’s move to approve the first obesity drug in 13 years seems to reflect a calculated risk by the regulator that the health hazards associated with weight loss drugs are eclipsed by the urgency of escalating medical costs associated with widespread obesity in the country.

The healthcare costs associated with obesity include an increased number of people with type 2 diabetes and complications derived from that condition, as well as gastrointestinal and cardiovascular problems, which all amount to more hospital stays.

Lorcaserin or Belviq, as the pharmaceutical companies branded it, was developed by Swiss drugmaker Arena Pharmaceuticals (NASDAQGS:ARNA) and has been licensed to Eisai to distribute in the U.S. market. The Japanese drugmaker has its U.S. headquarters in New Jersey.

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The drug is approved for use in adults with a body mass index of 30 or more, considered obese, or adults with a BMI of 27 or greater, considered overweight, and who have at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol, according to a statement from the FDA. In a recent clinical trial, it produced weight loss of 3 percent to 3.7 percent in a group that used the drug for one year compared with a group using a placebo.

Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, underlined the health problem the drug is designed to address in a statement:

“Obesity threatens the overall well-being of patients and is a major public health concern. … The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related co-morbid condition.”

Reuters quoted a research note from Cowen & Co. analyst Simos Simeonidis:

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

“It appears that the agency’s view has officially shifted towards ‘not treating obesity is a risk in and of itself, so we’re willing to put drugs in the market in order to help people lose weight, even if there’s risk associated.'”

Forbes noted what the FDA left out of its press release, which was almost as interesting as the main news:

It “makes no mention of tumors found in animals, which at one point appeared to be an issue for the drug. The FDA also doesn’t seem to be requiring echocardiograms to test for heart valve problems, another worry.”

If the FDA can tolerate the side effects of Belviq, then maybe approvals for other weight loss drugs, which have been delayed to address issues like side effects, are not far behind, as Pharmalot pointed out.

Thirteen years is a long time but not long enough to wipe out the memory of the ill effects of previously approved drugs like fenfluramine and dexfenfluramine, which caused heart valve damage before they were taken off the market.

The drugmaker still needs to do six post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke, according to the statement.