FDA approves Natazia (Bayer HealthCare) for Heavy Menstrual Bleeding

The FDA has approved a new indication for Natazia (estradiol valerate and estradiol valerate/dienogest) tablets, from Bayer HealthCare, for the treatment of Heavy Menstrual Bleeding (HMB) that is not caused by any diagnosed conditions of the uterus (womb), in women who choose an oral contraceptive (OC) for contraception. Natazia is the first and only oral contraceptive indicated for the treatment of HMB. Natazia was approved in May 2010 for the prevention of pregnancy. The contraceptive efficacy of Natazia has not been evaluated in women with a body mass index (BMI) greater than 30 kg/m2. This approval was based on two multicentre trials including a total of 421 women, of 18 years of age or older, with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged and/or frequent bleeding without organic pathology. Patients with HMB (defined as menstrual blood loss of 80 mL or more in at least 2 bleeding episodes during a 90-day run in phase) who were treated with Natazia achieved a statistically significant reduction in menstrual blood loss compared with patients in the placebo group (p<0.0001 for both studies).>