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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:

Is general: Yes