Date: 2012-03-15
Type of information: Granting of a Market Authorisation in the US
Product name: Natazia®
Compound: estradiol valerate and estradiol valerate/dienogest
Therapeutic area: Gynecology - Women\'s health
Action mechanism:
Company: Bayer (Germany)
Disease: heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb), in women who choose an oral contraceptive for contraception
Latest news: * On March 14, 2012, Bayer HealthCare Pharmaceuticals announced that the FDA has approved a new indication for Natazia® (estradiol valerate and estradiol valerate/dienogest) tablets 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. With this approval, Natazia® is the first and only oral contraceptive indicated for the treatment of HMB. The approval of Natazia® for this HMB indication was based on two identically-designed, multicenter, double-blind, randomized, placebo controlled trials – one in North America and one in Europe and Australia. The studies included a total of 421 women, who were 18 years of age or older, with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged and/or frequent bleeding without organic pathology. Subjects were treated for seven 28-day cycles with either Natazia® or placebo. The proportion of the intent-to-treat subjects with complete symptom relief (based on 8 strictly defined criteria for success during the 90-day efficacy assessment phase) was 29.2 percent in the Natazia group compared to 2.9 percent in the placebo group in the first study and 29.5 percent in the Natazia® group compared to 1.2 percent in the placebo group in the second study. 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 Most common adverse reactions (greater than or equal to two percent) in Natazia clinical trials included headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea or vomiting, acne, mood changes, and weight gain. 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-03-14
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
