A	B	C
1	Main
2		Brand Name	Forxiga
3		Generic Name	dapagliflozin
4		Economics	AZN
5		Mechanism	SGLT2 inhibitor - blocks glucose reabsorption in the kidney. Class plagued by UTIs. Dapa also has cancer signal: 0.4% of women got breast cancer versus 0.1% in placebo.
6		Timeline	4/19/12 EMEA summary of opinion positive. FDA gave CRL, AdCom voted 6-9 for approval based on safety issues.
7		Safety	Liver toxicity
8			9 breast cancer (0.4% of women) versus 0.0% or 0.1% in placebo.
9			7 bladder cancer cases versus 0 in control. 207/100,000 for dapa versus 53/100,000 for placebo.
10		Clinical Trials
11			Phase III metformin add-on - To be presented at EASD (September 2009)
12			24-week placebo-subtracted decline -0.4 to -0.5%. S.S. decreases in weight.
13			Genital fungal infections higher.
14
15			Phase IIB 12-week study vs metformin
16			A1C reductions similar to metformin.
17
18			Phase IIB 12-week add-on study vs control
19			-0.6 to -0.7% reduction in A1C after 12 weeks versus +0.1% for control.
20			4.4kg weight loss versus 1.9kg for control.
21			n=71 in each arm, large # of genital tract infections.