Johnson & Johnson's experimental diabetes drug might bring minorheart risks because it raised cholesterol levels in patient testing,according to federal drug reviewers.
In documents releasedTuesday, Food and Drug Administration staff experts conclude studiesshowed J&J's canagliflozin raised levels of LDL, or bad cholesterol,and slightly increased risk of heart attack, stroke or death, comparedto two other types of diabetes medications.
Data from nine largepatient studies also showed the pill increased risks of urinary tractinfections and fungal infections in the genital area. That's becausecanagliflozin works by boosting blood sugar excretion via urine, andgerms thrive on that sugar.
The studies didn't find other serious problems, such as weakening of bones, damage to the liver or kidneys, or various cancers.
Outsideadvisers to the FDA will review the data during a meeting Thursday andrecommend whether the agency should approve canagliflozin.
If theFDA approves the New Brunswick, N.J., company's drug, it would be thefirst in a new class of Type 2 diabetes medicines, called SGLT2inhibitors.
The agency rejected another experimental drug in theSGLT2 class, dapagliflozin from partners Bristol-Myers Squibb Co. andAstraZeneca PLC, a year ago. The FDA cited concerns about possibleliver damage and elevated rates of bladder and breast cancer.
Inrecent years, the FDA has required companies developing diabetes drugsto track cardiac side effects in patient testing. That's becausediabetes medicines are taken daily for many years, and one formerblockbuster, Avandia, was linked to higher heart attack risks. In 2010,the FDA restricted Avandia's use to patients not helped by any otherdiabetes treatments, and European regulators barred all sales ofAvandia.
The FDA has set a target date of March 31 to decidewhether to approve U.S. sales of canagliflozin. Johnson and Johnsonwould sell it under the brand name Invokana.