Orbán told Reuters that if current levels of uncertainty around Esmya persist, Richter may not issue its earnings guidance on February 8, when it is scheduled to publish Q4 earnings, Hungarian news agency MTI reported today.
Richter confirmed early in December that the European Medicines Agency (EMA) had started a review of Esmya after reports of serious liver damage in four patients treated with the drug.
Richterʼs communications director Zsuzsa Beke said at the time that available clinical data showed no link between Esmya and liver damage in the patients, adding that the cause may have been the use of other drugs at the same time or viral infections.
The EMA is expected to deliver a ruling on the drug in the first half of 2018, Orbán told Reuters. Richter earlier projected that sales of Esmya would reach EUR 85 million in 2017, MTI noted.
Esmya was approved by European Commission officials for long-term management of uterine fibroids in May 2015.
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