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Shares of pharmaceutical company Diurnal Group (LON: DNL) are trading lower on Thursday following the company’s announcement that it has decided to withdraw its application for the maintenance of Orphan Designation in Europe for Efmody.
The AIM-listed company said it made the decision after feedback from the Committee for Orphan Medicinal Products (COMP), an advisory committee to the European Medicines Agency (EMA).
Continuing the pursuit of an Orphan Designation would be likely to cause a “significant delay in its European commercial launch,” Diurnal said.
The first commercial launch is currently anticipated to be in the third quarter of 2021.
The Committee for Medicinal Products for Human Use, an advisory committee of the EMA, issued a favourable report to the European Commission recommending Efmody to treat adult and adolescent patients with the rare condition congenital adrenal hyperplasia. The drug's approval is not dependant on the maintenance Orphan Designation, and the company anticipates it will be approved in June 2021.
Despite the withdrawal of the maintenance of Orphan Designation application, Diurnal currently holds granted European patents for Efmody to treat patients with both CAH and adrenal insufficiency and believe these patents provide sufficient protection for Efmody until 2033.
Diurnal’s share price is currently down 5.14% at 70.2p following the news.
“Following the recent positive opinion from the CHMP we are focussed on the timely launch of Efmody in Q3 2021. Orphan Designation for Efmody in Europe is not critical to the commercial potential of the product in this market,” said Martin Whitaker, CEO of Diurnal.
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