Diurnal Group PLC AWMSG recommends Efmody for CAH in Wales (0990C)
07 Outubro 2022 - 3:00AM
UK Regulatory
TIDMDNL
RNS Number : 0990C
Diurnal Group PLC
07 October 2022
7 October 2022
Diurnal Group plc
("Diurnal" or the "Company")
AWMSG recommends Efmody(R) as treatment option for adolescents
and adults with congenital adrenal hyperplasia in Wales
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that the All Wales Medicines Strategy Group
(AWMSG) has recommended Efmody(R) (hydrocortisone modified-release
hard capsules) as an option for restricted use to treat adolescents
and adults with congenital adrenal hyperplasia (CAH) within NHS
Wales.
The AWMSG's recommendation means that Efmody(R) is available for
use as a second-line treatment option in adolescents with CAH not
adequately controlled on maximum guideline doses of
immediate-release hydrocortisone; and as a third-line treatment in
adults with CAH not adequately controlled on maximum guideline
doses of immediate-release hydrocortisone and/or prednisolone.
Diurnal will commercially roll-out Efmody(R) in Wales using its
existing sales and marketing infrastructure and supply chain.
Efmody(R) has been available for the treatment of CAH in the UK
since launch in October 2021. Efmody(R) is licensed for the
treatment of congenital adrenal hyperplasia in adolescents aged 12
years and older and in adults in Great Britain by the Medicines and
Healthcare products Regulatory Agency (MHRA).
Richard Bungay, Interim Chief Executive Officer of Diurnal
commented:
"We are delighted that, after a rigorous review, the AWMSG has
recognised the potential for Efmody(R) to address important unmet
needs in patients suffering with CAH. Diurnal believes the use of
this medicine will improve the lives of adults and adolescents in
Wales living with this rare disease."
For further information, please visit www.diurnal.co.uk or
contact:
+44 (0)20 3727
Diurnal Group plc 1000
Richard Bungay, Interim Chief Executive Officer
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0)20 7886
and Corporate Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Alex Davis
Notes to Editors
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty
pharmaceutical company dedicated to developing hormone therapeutics
to aid lifelong treatment for rare and chronic endocrine
conditions, including congenital adrenal hyperplasia, adrenal
insufficiency, hypogonadism and hypothyroidism. Its expertise and
innovative research activities focus on circadian-based
endocrinology to yield novel product candidates in the rare and
chronic endocrine disease arena.
For further information about Diurnal, please visit
www.diurnal.com
About congenital adrenal hyperplasia
Congenital adrenal hyperplasia (CAH) is an orphan condition
caused by deficiency of adrenal enzymes, most commonly
21-hydroxylase. This enzyme is required to produce the adrenal
steroid hormone, cortisol. The block in the cortisol production
pathway causes the over-production of male steroid hormones
(androgens), which are precursors to cortisol. The condition is
congenital (inherited at birth) and affects both sexes. The
cortisol deficiency and over-production of male sex hormones can
lead to increased mortality, infertility and issues during sexual
development including ambiguous genitalia, premature (precocious)
sexual development and short stature. Sufferers, even if treated,
remain at risk of death through an adrenal crisis.
Current therapy for CAH uses a variety of generic glucocorticoid
(steroid) preparations including hydrocortisone, dexamethasone and
prednisolone, with no standard treatment regimen. Approximately
two-thirds of CAH patients are estimated to have poor disease
control, leading to elevated androgen levels. The condition is
estimated to affect a total of approximately 41,000 patients in
Europe.
About Efmody(R) (hydrocortisone modified-release hard
capsules)
Efmody(R) is a preparation of hydrocortisone that has been
specifically designed to mimic the circadian rhythm of cortisol
when given in a twice-a-day "toothbrush" regimen (administered last
thing at night before sleep and first thing in the morning on
waking) to control androgen excess and chronic fatigue in patients
with diseases of cortisol deficiency. The first indication for
Efmody(R) is Congenital Adrenal Hyperplasia (CAH) in adults and
adolescents (children older than 12 years of age). Efmody(R) has
been extensively studied in 239 human subjects including 138 CAH
patients who have taken part in clinical trials in Europe and the
US.
The MHRA and European Commission marketing authorisation
approval of Efmody (R) was based on a Phase 3 study conducted in a
total of 122 patients enrolled across 11 clinical sites, including
sites in Great Britain, the largest ever interventional clinical
trial completed in CAH. The Phase 3 data was supported by detailed
analysis of data from an open-label safety extension study for
patients completing treatment in the Phase 3 study, which is
assessing the impact of treatment with Efmody (R) over an extended
period, with a number of patients on this trial having been treated
for over 5 years. Summary of Product Characteristics (SmPC) for UK
including Northern Ireland) can be found here .
Date of Preparation: October 2022 Code: CH EU-GLO-0011
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