FDA actions

FDA actions

The FDA has approved the first new drug for lupus (systemic lupus erythematosus) since 1955. Belimumab is a fully human monoclonal antibody the targets human soluble B-lymphocyte receptor stimulator protein. It is indicated for the treatment of adult patients with active, autoantibody-positive lupus who are receiving standard therapy. In two pivotal studies, the drug was found to reduce disease activity compared to placebo plus standard therapy. More deaths and serious infections were reported for belimumab compared to placebo, and it does not appear to be effective in people of African or African American heritage (in whom the disease is three times more common), although more studies are needed to confirm this finding. Belimumab is marketed by GlaxoSmithKline as Benlysta.

The FDA has approved a phosphodiesterase type 4 inhibitor to reduce the number of exacerbations from severe COPD associated with chronic bronchitis. Roflumilast is a once daily oral pill that reduces excess mucus and cough. It does not appear to benefit COPD that involves primarily emphysema. The approval was based on two Phase 3 studies of more than 1500 patients. An accompanying medication guide informs patients of the potential risk of mental health problems including changes in mood, thinking, or behavior, as well as unexplained weight loss. Roflumilast is marketed by Forest Pharmaceuticals as Daliresp.

The FDA has approved a new angiotensin II receptor antagonist, the eighth introduced to the American market. Azilsartan medoxomil is approved for the treatment of hypertension in 40 mg and 80 mg once daily doses. The drug is touted as being more effective in lowering blood pressure than valsartan or olmesartan based on clinical trials. Like other angiotensin II receptor blockers, the drug will carry a box warning regarding pregnancy. Azilsartan is marketed by Takeda Pharmaceuticals as Edarbi.

Zostavax, Merck's vaccine for the prevention of shingles, has been approved for use in individuals ages 50-59. It previously was approved only for those 60 and older. The approval was based on a placebo-controlled trial of more than 20,000 individuals 50-59 years of age. The vaccine reduced the risk of developing shingles in this group by approximately 70%.

The FDA has approved ipilimumab for the treatment of late stage (metastatic) melanoma. The drug is a monoclonal antibody that blocks cytotoxic T-lymphocyte antigen (CTLA-4). The approval was based on a single study of 676 patients with melanoma who had stopped responding to other therapies. When compared to an experimental tumor vaccine, those receiving ipilimumab lived an average of 3.5 months longer (10 months vs 6.5 months). Autoimmune reactions were common including fatigue, diarrhea, rash, endocrine deficiencies, and colitis. Severe to fatal autoimmune reactions were seen in 13% of treated patients. Ipilimumab is manufactured by Bristol-Myers Squibb and marketed as Yervoy.