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 The European Medicines Agency (EMA) has opened a review into Esmya
after four reports of serious liver damage in patients treated with
the drug, three of which ended up requiring liver transplants.
"Based on the clinical data at our disposal, we consider that there
is no demonstrable link between liver damage and treatment with
Esmya," spokeswoman Zsuzsa Beke said, adding that Richter believed
the product should not be suspended.
The uncertainty around the medicine, which Richter expects to bring
in 85 million euros of revenue this year, hit the company's share
price, which touched 8-1/2-month lows of 6,371 forints in early
trade. At 1125 GMT the shares were down by over 5 percent at 6,456
forints.
"Given the seriousness of the observed liver injury and its possible
link to the medicine, a more in-depth review is warranted," the EMA
said in a statement on its website.
The body said its risk assessment committee would look at all
available data and determine whether there were any implications for
the use of Esmya, which accounted for about 6 percent of Richter's
total revenues in the first nine months of this year.
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Beke said Richter was fully cooperating with the EMA, adding that
currently about 670,000 patients were being treated with Esmya,
first authorized in the EU in 2012 for the treatment of moderate to
severe symptoms of uterine fibroids.
Beke said additional factors, such as the affected patients being
treated concurrently with other medicines, or viral infections,
could have contributed to the reported cases of liver damage.
(Reporting by Gergely Szakacs and Marton Dunai; Editing by Edmund
Blair, Greg Mahlich)
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