Diabetes Q&A

FDA Roundup: New Options for Diabetes, Hypercholesterolemia

Repatha – High Cholesterol

The FDA has approved Repatha (evolocumab) for the treatment of patients with uncontrolled low-density lipoprotein (LDL) cholesterol levels.1

Repatha, the second PCSK9 inhibitor to be approved by the FDA, is administered via injection and approved for use in conjunction with diet and statin therapy in adult patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease.
_______________________________________________________________________________________________________________________________________________________________________

RELATED CONTENT
Can PCSK9 Inhibitors Improve Hypercholesterolemia Outcomes
Hypercholesterolemia Associated with Greater Psoriasis Risk
_______________________________________________________________________________________________________________________________________________________________________

The drug’s safety and efficacy was tested in a 52-week placebo-controlled trial and 8 12-week placebo-controlled trials. Participants taking Repatha had an average reduction in LDL cholesterol of 60% over placebo.

The most common side effects are nasopharyngitis, flu, back pain, and injection site reactions.

Dexcom G5 Mobile CGM System – Glucose Monitor

The FDA has approved the first continuous glucose monitoring (CGM) system that directly interacts with a smartphone and does not require a receiver.2

The device sends real-time glucose information using wireless Bluetooth technology to an iOS app (an Android app is forthcoming).

The system allows up to 5 individuals to follow these results, allowing parents and caregivers to monitor glucose levels remotely.

Synjardy – Type 2 Diabetes

The FDA has approved Synjardy (empagliflozin and metformin hydrochloride) for the treatment of adults with type 2 diabetes.3

The drug is a combination of empagliflozin and metformin, and is the third combination drug utilizing empagliflozin to be approved in the United States.

It is indicated for use, in combination with diet and exercise, to improve glycemic control in adults with type 2 diabetes, and not for the treatment of type 1 diabetes or diabetic ketoacidosis.

The drug includes a boxed warning of lactic acidosis, a serious complication related to treatment with metformin.

—Michael Potts

References:

  1. FDA. FDA approves Repatha to treat certain patients with high cholesterol [press release]. August 27, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm
  2. Dexcom.
  3. FDA approves dexcom g5® mobile continuous glucose monitoring system [press release]. http://www.dexcom.com/news/1257506247-fda-approves-dexcom-g5%C2%AE-mobile-continuous-glucose-monitoring-system
  4. Lilly. U.S. FDA approves Synjardy® (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes [press release]. https://investor.lilly.com/releasedetail.cfm?ReleaseID=929164.