REG - Shield Therapeutics - FDA approves extension for ACCRUFeR®

Shield TherapeuticsAnnouncement

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RNS Number : 3781M  Shield Therapeutics PLC  22 December 2025

Shield Therapeutics plc

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

 

US FDA approves extension of the indication for ACCRUFeR® to include

children 10 years and older with iron deficiency (ID)

 

London, UK, 22 December 2025: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces that the US Food and Drug Administration (FDA), following a priority
review of the clinical supplement, has approved the extension of the
indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR®
is now indicated for the treatment of iron deficiency in adult and pediatric
patients 10 years of age and older.

 

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 plans to file for a further extension of the indication to include
children 1 month and above in conjunction with the submission of an NDA for a
new pediatric formulation (ferric maltol suspension) which was used in the
successful FORTIS Phase 3 study in this population. If approved, this
formulation may also offer an alternative approach for adults who can't
swallow our current capsule formulation.

 

Anders Lundstrom, CEO of Shield, commented: "We are delighted with the FDA
approval of ACCRUFeR®, making it available to the adolescent population, who
now can 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

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel/Christopher Golden                                                                 +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. 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., which also has
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, including secondary
endpoints and pharmacokinetic (PK) sub-study parameters, will be submitted for
peer-review and subsequent presentation/publication. The trial is the final
study in the comprehensive paediatric development program that Shield
committed to implement with both the European EMA and the US FDA.

 

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