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2nd March, 2018

FDA delays verdict for Richter’s Esmya

The US Food and Drug Administration said it has extended its deadline to August to issue its verdict on whether Richter’s original drug Esmya, a treatment for uterine myoma, could be launched in the US, Richter’s US partner Allergan announced.

The drug has been launched in Latin America and Europe.

But the European Medical Agency (EMA) suspended treatments in February after reports of serious liver injury in patients taking the drug.

The EMA is scheduled to conclude its review in May and no new treatment may begin until then. Richter has said it will book a Ft 42 billion impairment loss related to the issue.

Richter has maintained that the drug has no demonstrable link with liver damage.

Brokerage Jefferies has slashed its target price for Richter to Ft 5,695, from Ft 8,355, as it removed Esmya from its price forecast when calculating the share’s fair value, Portfolio said. The drug is unlikely to get the green light for the US market this year, Jefferies forecast.

Sources regularly consulted, with abbreviations used in text: Népszabadság (N); Magyar Hírlap (MH); Világgazdaság (VG); Napi Gazdaság (NG); Magyar Nemzet (MN); Népszava (Nsz); Kossuth Rádió news (KR); nightly TV news (TV).

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