Drug Update: February 2016 Issue 2

FDA Drug Review News

U.S. Food and Drug Administration Approves Concentrated Insulin Pen

Last month, the FDA approved Humulin® R U-500 KwikPen® (insulin human injection), the first prefilled pen device that contains 500 units of insulin per milliliter. The insulin contained within this KwikPen, Humulin R U-500, is five-times more concentrated than standard U-100 insulin and was previously only available in a vial that required administration with either a U-100 insulin syringe or a tuberculin syringe. The U-500 KwikPen is intended to eliminate the requirement for dose conversions that are needed with use of the vial and syringes. As Humulin R U-500 is a concentrated form of human insulin, it is only indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus type 1 or type 2 that require more than 200 units of insulin per day. Read more

Drug Update: February 2016 Issue 1

FDA Drug Review News

U.S. Food and Drug Administration Grants Priority Review to New Leukemia Drug

In January of this year, the U.S. Food and Drug Administration (FDA) granted Priority Review to the New Drug Application (NDA) for venetoclax. Venetoclax is being reviewed for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy, including patients with the 17p deletion mutation. Priority Review is given if the drug is likely to provide an important advance to existing care and shortens the FDA review process from ten months to six months.

Last April, venetoclax received Breakthrough Therapy Designation by the FDA for the treatment of CLL in previously treated patients with the 17p deletion mutation. Breakthrough Therapy Designation is given when preliminary clinical data demonstrates the drug may provide significant progress over current therapies. CLL is a cancer of the bone marrow in which a certain type of white blood cell is produced in excess. It is the most common type of leukemia in the Western world, and it is expected about 14,000 individuals in the U.S. will be diagnosed with CLL this year. Venetoclax works by inhibiting a protein called B-cell lymphoma-2 (BCL-2) and is being jointly developed by AbbVie, Genentech, and Roche. It is anticipated venetoclax will receive approval as a single agent therapy for the CLL indication in the first half of 2016. Read more