Date: 2012-02-23
Type of information: Granting of a Market Authorisation in the EU
Product name: Esmya®
Compound: ulipristal acetate
Therapeutic area: Women health - Fertility
Action mechanism: The active substance of Esmya® is ulipristal acetate, a selective progesterone receptor modulator, characterised by a tissue-specific partial progesterone antagonist effect. It acts by depriving uterine fibroids of growth stimulation due to progesterone.
Company: Preglem (Switzerland) member of the Richter Group (Hungary)
Disease: pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
Latest news: * On 15 December 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Esmya®, 5mg, tablet, intended for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The duration of treatment is limited to 3 months.
The treatment consists of one tablet of 5 mg to be taken orally once daily for up to 3 months, and it should be started during the first week of a menstrual cycle. There are no data available on treatment with a duration longer than 3 months or on repeat courses of treatment. Therefore, treatment duration should not exceed 3 months.
The benefits with Esmya® are its ability to reduce fibroid-related bleeding, anaemia and fibroid size. Ulipristal showed better efficacy compared to placebo (a dummy) at reducing bleeding and anaemia, and fibroid volume.
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:
UE authorization: 2012-02-23
Favourable opinion UE: 2011-12-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: