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Diurnal receives 'positive opinion' from EMA for Efmody product; Q3 2021 commercial launch
StockMarketWire.com
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Pharmaceutical group Diurnal has announced that the European Medicine Agency (EMA) has issued a positive opinion for its second product in Europe, with the commercial launch expected to go ahead in the third quarter of 2021.
The Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the EMA, has issued a positive opinion to the European Commission recommending Efmody, which had the development name Chronocort, for treatment of adult and adolescent patients with the rare condition congenital adrenal hyperplasia.
The company said it anticipates formal approval of marketing authorisation from the European Commission in June 2021, in accordance with the 67-day timeline following the adoption of the positive opinion by the CHMP, together with a decision on grant of orphan drug status.
Diurnal said it has already commenced market access activities in its target European territories, with the first commercial launch anticipated in the third quarter of 2021.
Chief executive Martin Whitaker said: 'We are delighted that the CHMP endorses Efmody as a treatment option for adult and adolescent patients suffering from congenital adrenal hyperplasia.
'We look forward to expanding our commercial portfolio with the planned launch of Efmody across Europe alongside our first product Alkindi, to provide life-long treatment for patients with congenital adrenal hyperplasia, enabling Diurnal to continue to drive towards becoming a world-leading specialty endocrinology business.'
At 1:50pm: (LON:DNL) Diurnal Group Plc share price was 0p at 55.5p
Story provided by StockMarketWire.com
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