REG - Shield Therapeutics - EMA approves extension - to include adolescents

Shield TherapeuticsAnnouncement

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RNS Number : 7136Y  Shield Therapeutics PLC  31 March 2026

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 

European Medicines Agency approves extension of the indication to include
adolescents

 

London, UK, March 31 2026: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces that the European Medicines Agency (EMA) have published the CHMP
meeting highlights in which they confirm their adoption of a positive opinion
for the extension of the indication for FeRACCRU® (ferric maltol) to include
adolescents. FeRACCRU® will now be indicated for the treatment of iron
deficiency in adult and pediatric patients 12 years of age and older. EMA have
also confirmed that all measures in the agreed Pediatric Investigation Plan
(PIP) for FeRACCRU® have been fulfilled.

 

The indication expansion was supported by positive results from the Phase 3
pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy,
safety, and tolerability of the new oral liquid pediatric formulation in
children aged 1 month and above with iron deficiency, presenting as iron
deficiency anemia (IDA).

 

Shield's licensing partner, Norgine B.V. holds the marketing authorisation and
is responsible for commercialising FeRACCRU® in the European Union. Shield
will receive a milestone payment of €500,000 from Norgine related to this
EMA approval for the term of the agreement.

 

Anders Lundstrom, CEO of Shield, commented: "We are delighted with the EMA
approval of FeRACCRU® for an adolescent population.  This follows on from
the FDA approval of ACCRUFeR® for adolescents reported in December 2025,
further expanding the geographic and age range of patients who can now benefit
from a much needed safe and effective oral iron treatment."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO                                                                          Investorrelations@shieldtx.com

 Stephanie Hicks, Investor Relations
 https://shieldtherapeutics.com/link/r69DGe
 (https://shieldtherapeutics.com/link/r69DGe)

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel                                                                                    +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 

 

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

Clinically low iron levels (aka iron deficiency, ID) can cause serious health
problems for adults of all ages, across multiple therapeutic areas. Together,
ID and ID with anemia (IDA) affect about 20 million people in the US and
represent a $2.3B market opportunity. As the first and only FDA approved oral
iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet
medical need for both physicians and patients and is now the #1 branded
prescription oral iron the market today (*data source - IQVIA Xponent
PlanTrak).

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. The drug has a novel mechanism of absorption
compared to other oral iron therapies and has been shown to be an efficacious
and well-tolerated therapy in a range of clinical trials. More information
about ACCRUFeR®/FeRACCRU®, including the product label, can be found at:
www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(http://www.feraccru.com) .

 

 

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers
ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anemia. The Company has
launched ACCRUFeR® in the U.S. to include pediatric patients 10 years of age
and older with an exclusive, multi-year collaboration agreement with Viatris.
Outside of the U.S., the Company has licensed the rights to five specialty
pharmaceutical companies. FeRACCRU® is commercialised in the UK and European
Union by Norgine B.V., to include pediatric patients 12 years of age and older
and also have marketing rights in Australia and New Zealand. FeRACCRU® is
also commercialised in Canada by Kye Pharmaceuticals Inc. Shield also has an
exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd.,
for the development and commercialisation of ACCRUFeR®/FeRACCRU® in China,
Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of
Korea, and with Medleap Pharma Company Limited, a subsidiary of VITAL-NET Inc.
for Japan.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

Details of the FORTIS/ST10-01-305 Phase 3 study

The open label randomized Phase 3 study included children aged 1 month to 17
years with mild to moderate IDA, who also had serum ferritin levels below 30
μg/L or ferritin levels below 50 μg/L and transferrin saturation below
20%.  Children aged 2 to 17 years were randomized 1:1 to receive either
ferric maltol (N=31) or ferrous sulphate

(N = 30).  Children 1 months to under 2 years (N=4) were all assigned to
receive ferric maltol treatment. The full data sets have been submitted for
peer-review and subsequent presentation/publication. The trial is the final
study in the comprehensive pediatric development program that Shield committed
to implement with both the European EMA and the US FDA.

 

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