Monthly News Round Up - February 2013
Osphena Approved to Treat Painful Sex in Women
The U.S. Food and Drug Administration (FDA) has approved Osphena (ospemifene), an oral estrogen agonist/antagonist with selective tissue effects, to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse). Dyspareunia is a condition that can result in thinner and drier vaginal tissues due to reduced levels of estrogen that occur during menopause. Generally, when estrogenic products are prescribed in postmenopausal women with an intact uterus, the combined use of a progestin should be considered to reduce the risk of endometrial cancer. Women should see their health care professional if they experience any unusual bleeding.
Kadcyla Approved Under FDA Priority Review Program
Kadcyla (ado-trastuzumab emtansine) has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for HER2-positive, metastatic (late-stage) breast cancer. Kadcyla is intended for patients who were previously treated with trastuzumab, an anti-HER2 therapy, and taxanes, another class of chemotherapy drugs. In a clinical study of 991 patients randomly assigned to receive Kadcyla or lapatinib plus capecitabine, patients treated with Kadcyla had a median progression-free survival of 9.6 months compared to 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus capecitabine group.
Celegene’s Pomalyst Approved for Advanced Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved Pomalyst (pomalidomide) to treat patients with multiple myeloma who have not responded to treatment and have progressed after being treated with at least two prior cancer therapies. Multiple myeloma is a form of blood cancer that primarily affects older adults. Pomalyst, an analogue of thalidomide, is contraindicated in pregnancy and is only available through a restricted distribution program. In trials, over 29 percent of patients treated with Pomalyst plus low-dose dexamethasone had a complete or partial response with a 7.4-month median duration of response. In July 2012, FDA also approved Kyprolis (carfilzomib) to treat multiple myeloma.
FDA Approves Orphan Drug Ravicti for Rare Urea Cycle Disorder
The U.S. Food and Drug Administration (FDA) has approved Ravicti (glycerol phenylbutyrate) for the chronic management of certain urea cycle disorders (UCDs) in patients ages 2 years and older. UCDs are rare genetic disorders manifest by enzyme deficiencies in the urea cycle, a series of biochemical steps normally required to remove ammonia from the blood. When nitrogen accumulates in the brain it can cause brain damage, coma or death. Ravicti was compared to Buphenyl (sodium phenylbutyrate), another UCD treatment, in a clinical trial with 44 patients. Blood testing showed Ravicti was as effective as Buphenyl in controlling ammonia levels.
Delzicol FDA-Approved for Ulcerative Colitis Treatment and Remission
The U.S. Food and Drug Administration (FDA) has approved Delzicol (mesalamine), a 400 mg delayed-release aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis (UC) and for the maintenance of remission of ulcerative colitis. For treatment of UC, the oral dose is 800 mg three times a day for six weeks, and for maintenance of remission of UC, the oral dose is 1.6 grams per day in divided doses. It is important to note that two Delzicol 400 mg capsules have not been shown to be bioequivalent to one Asacol HD (mesalamine) delayed-release 800 mg tablet. Delzicol launch is anticipated to occur in March 2013.
Posted: February 2013