LONDON, Nov. 6 -- The government of the United Kingdom issued the following news:

The Medicines and Healthcare products Regulatory Agency (MHRA) has approvedSiiltibcy(rdESAT-6 and rCFP-10),adiagnostic aid for detection ofMycobacterium tuberculosisinfection, includingtuberculosisdisease,in adults andchildren.

Tuberculosis (TB) is an infectious disease most commonly affecting the lungs,but capable of spreading to other parts of the body. It isusuallytransmitted through the air.

Siiltibcyisgivenas aninjection inthe skinofthe forearm.Itcontainstwo active substances,rdESAT-6 and rCFP-10, which are proteins specific ofMycobacterium tuberculosisthathave been produced in a laboratory.

If a person has been infected withMycobacterium tuberculosis, her/his immune system will respond by producingcytokines (inflammatory proteins) which cause induration (hardening) at the site where SIILTIBCY was injected thatusually occurs 48 to 72 hours after injection.The size of the induration will be measured todetermineif the person is infected withM. tuberculosisor hastuberculosis.

Siiltibcyhas been evaluated in3main studiesinvolvingover2000participants, including children.

The most common sideeffectwas pruritus(itching) at the injection site, which affected more than1 in 10 people.A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be available on the MHRA website within 7 days of approval.

As with allmedicinalproducts, the MHRA will keep the safety and effectiveness ofSiiltibcyunder closereview.

Anyone who suspects they are having a side effect from this product is encouraged to talk to their doctor, pharmacist, or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk) or by searching the Google Play or Apple App stores forMHRA Yellow Card.

ENDS

Notes to editors

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The approval was granted to Serum Life Sciences Ltd on 31 October 2025.

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More information can be found in the Summary of Product Characteristics and Patient Information Leaflet, which will be published on the MHRA Products website within 7 days of approval.

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This product wassubmittedand approved via an international recognition procedure.

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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

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The MHRA is an executive agency of the Department of Health and Social Care.

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For media enquiries, please contactnewscentre@mhra.gov.uk or call 020 3080 7651.

Disclaimer: Curated by HT Syndication.