February 27, 2016

Saralyn Mark, MD Feedback from TappMD Expert
Saralyn Mark, MD
Diabetes Treatment
A new class of diabetes drugs called sodium glucose co-transporter 2 has been approved, but observation for side effects needs to be done. Prior experiences have shone that some diabetes drugs can result in increased heart and liver diseases.

(Reuters) – U.S. health regulators have approved a new diabetes drug from Johnson & Johnson, making it the first in its class to be approved in the United States.

The U.S. Food and Drug Administration approved the drug, Invokana, after data showed it was effective in lowering blood sugar in patients with Type 2 diabetes, the most common form of the disease.

The FDA has asked for five postmarketing studies for the drug including a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study and two pediatric studies, the agency said in a statement on its website. ()

Invokana is expected to generate sales in 2016 of around $468 million, according to analysts’ estimates compiled by Thomson Reuters.

Known chemically as canagliflozin, Invokana is a member of a new class of diabetes treatments called sodium-glucose co-transporter-2 (SGLT2) inhibitors that lower blood sugar by blocking reabsorbtion of glucose and increasing its excretion in urine.

Earlier this year, an advisory committee to the FDA discussed the benefits and risks of canagliflozin with a focus on any potential increased risk of heart attack or stroke.

A clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event compared with just one patient taking a placebo. After that, the imbalance was reversed. The drug also caused a slight increase in unhealthy LDL cholesterol.

In January, 2012, the FDA rejected a similar drug, dapagliflozin, made by Bristol-Myers Squibb Co and AstraZeneca Plc, citing concerns over a possible increased risk of cancer and liver injury. The drug was subsequently approved in Europe under the brand name Forxiga.

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Saralyn Mark, MD

Saralyn Mark, MD, an endocrinologist, geriatrician and women's health specialist, was the first Senior Medical Advisor to the Office on Women's Health within the Department of Health and Human Services for 11 years and to the National Aeronautics and Space Administration (NASA). As Senior Medical Advisor, Dr. Mark was responsible for the development and analysis of initiatives and programs on emerging technologies, public health preparedness, physician workforce issues, sex and gender-based medicine and women's health on Earth and in Space.

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