Advicenne Receives MHRA Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment of dRTA
02 Luglio 2021 - 7:00AM
Advicenne Receives MHRA Approval to Market Sibnayal™ (ADV7103) in
the UK for the Treatment of dRTA
Advicenne Receives MHRA
Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment
of dRTA
Paris, France, 2nd July 2021 – 7 am CEST
– Advicenne (Euronext: ADVIC), a specialty pharmaceutical
company dedicated to developing and commercializing innovative
treatments for those suffering from rare renal diseases, is pleased
to announce that the Medicines & Healthcare products Regulatory
Agency (MHRA) has today granted marketing authorisation for
Sibnayal™ (ADV7103) in the UK, for the treatment of distal renal
tubular acidosis (dRTA).
With this authorization, and following the
recent approval by the European Commission to market Sibnayal™ for
the treatment of dRTA in the European Union, Advicenne is now able
to bring to market in the EU and the UK the first and only
label-approved drug for the treatment of dRTA in adults,
adolescents and children aged one year and older. Advicenne now has
the opportunity to make a significant difference to patients
suffering from dRTA, classified as an orphan condition in
Europe.
Didier Laurens, Chief Executive Officer of
Advicenne said: “We welcome the approval by the MHRA of
Sibnayal™ which enables us to provide a much needed treatment to
patients in the United Kingdon affected by dRTA. With this
approval, and following the marketing authorization by the European
Commission earlier this year, we are now able to make a difference
to the lives of the thousands of people affected by this rare
disease. Our first priority is now to finalize a distribution
agreement for Sibnayal™ in Europe.”
Sibnayal™ is a multi-particulate formulation in
2mm granules, a novel pioneering delivery technology created by
Advicenne that contains two active pharmaceutical ingredients. This
approach not only has led to an excellent effectiveness in
controlling metabolic acidosis, but also to ease the administration
and aid compliance and quality of life in patients of all ages.
About dRTA
Distal renal tubular acidosis (dRTA) is an
orphan disease characterized by a failure in the renal excretion of
acids generated through metabolism and for which there is no
approved treatment. The excess of acids thus accumulated in the
blood leads to an imbalance in pH (acidosis) as well as multiple
other complications such as growth retardation and rickets (a
disease affecting bone development) in children, and a series of
metabolic disorders such as low potassium levels, elevated calcium
in the urine resulting in kidney stones, the formation of calcium
deposits in the kidneys (calcinosis) as well as possible kidney
failure.
Whether genetic or acquired as a consequence of
an immune disease, dRTA affects an estimated 30,000 patients in
Europe and approximately 20,000 in the United States.
About Advicenne
Advicenne (Euronext: ADVIC) is a pharmaceutical
company founded in 2007, specializing in the development of
innovative treatments in Nephrology. Its lead drug candidate is
currently in late-stage clinical trials for two kidney diseases:
distal renal tubular acidosis and cystinuria. ADV7103 has just
received a positive CHMP opinion for the treatment of dRTA.
Headquartered in Paris, Advicenne has been listed on the Euronext
Paris stock exchange since 2017 and was cross-listed on the
Euronext Brussels stock exchange in 2019.
For additional information see:
https://advicenne.com/
CONTACTS
Advicenne David Solomon, ChairmanDidier Laurens, CEO+33 (0)4
66 05 54 20Email: investors@advicenne.com |
Ulysse CommunicationMedia relationsBruno Arabian+33 (0)6 87
88 47 26Email: advicenne@ulysse-communication.com |
Consilium Strategic CommunicationsMary-Jane Elliott, Ashley
Tapp, Davide Salvi+44 (0)20 3709 5700Email:
advicenne@consilium-comms.com |
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