Diurnal withdraws EMA orphan designation request for Efmody/Chronocort

15 April 2021

UK endocrine diseases specialist Diurnal Group (AIM: DNL) has withdrawn its application for maintenance of orphan designation in Europe for Efmody (hydrocortisone modified-release hard capsules), a drug formerly known as Chronocort.

This follows feedback from the Committee for Orphan Medicinal Products (COMP), an advisory committee to the European Medicines Agency (EMA).

Diurnal has decided that continuing pursuit of an orphan designation for the drug would be likely to cause a significant delay in its European commercial launch. First commercial launch is currently anticipated to be in the third quarter of this year.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK