Drug Update: May 2016 Issue 2

FDA Drug Review News

Advisory Panel to the FDA Recommends Prescription Acne Medication be Available Over-the-Counter

In mid-April, an advisory panel to the U.S. Food and Drug Administration (FDA) voted 16 to 0 that the prescription topical acne agent adapalene gel 0.1% (Differin®) was safe for over-the-counter (OTC) use. However questions persist on the labeling of the product due to concerns regarding its safety in women who are pregnant or may become pregnant. Overall adapalene is thought to have a low risk of birth defects and wide margin of safety.

Adapalene is a topical retinoid derived from vitamin A and is used once daily. It is FDA-approved for the treatment of acne in adults and children ages 12 and older. It is estimated 85% of adolescents and 12% of adult women are affected with acne, and over-the-counter availability of this medication would be expected to help a significant portion of patients suffering from acne.

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Drug Update: May 2016 Issue 1

New Drug Approvals

U.S. Food and Drug Administration (FDA) Approves New Drug for Leukemia

Last month, the FDA approved Venclexta® (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and have a chromosomal abnormality known as the 17p deletion. Venclexta is an oral tablet indicated for once-daily use and requires the specific deletion mutation be confirmed with the FDA-approved companion diagnostic test prior to initiation. Venclexta was granted accelerated approval on the basis of overall response rate and continued approval may require confirmatory trials demonstrating benefit.

Chronic lymphocytic leukemia (CLL) is an incurable form of leukemia and is characterized by abnormal growth and proliferation of white blood cells called lymphocytes. In the United States (U.S.), about 15,000 adults are diagnosed with CLL annually. Patients with the 17p deletion mutation are generally difficult to treat, usually have a poor prognosis and have an expected survival of less than 2 to 3 years. Venclexta has a novel mechanism of action and works by inhibiting a protein called B-cell lymphoma 2 (BCL-2). This protein prevents cells from dying and can be present at increased levels in CLL cells. By inhibiting BCL-2, Venclexta allows for cells to die naturally. Read more