The European
Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP)
grants marketing authorization for Ulipristal Acetate (Gedeon Richter) as
pre-operative treatment for uterine fibroids.
Ulipristal
is a selective progesterone receptor modulator used for intermittent treatment
for moderate to severe symptoms of uterine fibroids in women of reproductive
age. It is also used as a pre-operative treatment in women scheduled for a
uterine fibroid surgery, where it helps reduce bleeding, anemia and fibroid
size. It will be available as 5 mg tablet upon approval.
The
application for ulipristal approval was an informed consent application, which
means that reference is made to an already authorized medication upon obtaining
consent to the use of their dossier in the application procedure. The reference
product for Gedeon Richter Ulipristal was Esmya.
The approval
further recommends that the drug should only be prescribed by physicians who
are experienced in the treatment of fibroids. The common side effects of the
drug include endometrial thickening, amenorrhea, and hot flushes.
However,
European Union drug regulators have expressed concerns about the side effects
on the liver by Esmya in the past. In December 2017, the EMA opened an
investigation about liver injury by the drug, followed by a monthly
recommendation of liver function test in women taking Esmya by the EMA's
Pharmacovigilance Risk Assessment Committee (PRAC).
Meanwhile,
the United States FDA announced in February 2018 that it had extended the
review of ulipristal new drug application (NDA) to August 2018.
