FDA panel backs novel diabetes pill from J&J
A panel of federal health experts has ruled that an experimental diabetes drug from Johnson & Johnson is safe and effective, though lingering safety questions must be tracked in long-term studies.
The Food and Drug Administration's panel of diabetes experts voted 10-5 in favor of J&J's canagliflozin to treat type 2 diabetes. The drug is part of a new class of medications that work by increasing the levels of blood sugar excreted via urine.
Panelists said the drug could be useful in combination with existing diabetes medications. However, they raised concerns about low levels of heart attack, stroke and urinary tract infections seen in the first year of testing. Almost all panelists recommended that the company track those problems over time to tell whether they get worse.