Serum Life Science Europe GmbH (SLS Europe) and Bilthoven Biologicals (BBio) have announced a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for SIILTIBCY, a novel skin test for tuberculosis (TB). This test is poised to become the first in Europe capable of accurately detecting TB infection regardless of prior BCG vaccination, addressing a significant unmet need in TB diagnostics. The European Commission is expected to make a final decision on marketing authorization by the end of 2024.
The positive recommendation is based on comprehensive manufacturing and clinical data demonstrating SIILTIBCY's accuracy and safety. Pivotal Phase 3 clinical trials across Europe and Africa, involving over 2,500 participants, validated the test's effectiveness in diagnosing TB. These findings were published in reputable medical journals, including The Lancet Respiratory Medicine.
Addressing a Critical Diagnostic Gap
Traditional TB skin tests often yield false-positive results in individuals vaccinated with BCG due to cross-reactivity. SIILTIBCY, already marketed in India as Cy-Tb, utilizes ESAT-6 and CFP-10 antigens to provide high specificity in a field-friendly format, thereby improving diagnostic accuracy and reducing the potential for misdiagnosis. This advancement is particularly crucial in regions with high BCG vaccination rates.
Adar Poonawalla, CEO of Serum Institute of India, stated, "The positive CHMP opinion for SIILTIBCY is a watershed moment in our fight against tuberculosis... As we prepare to introduce SIILTIBCY to the European market, we’re offering a powerful new tool that could support global eradication efforts."
Strategic Partnership for European Rollout
Following potential approval by the European Commission, SIILTIBCY will be made available to EU Member States. SLS Europe will serve as the Marketing Authorization Holder, overseeing regulatory compliance and product safety. BBio will handle import, release, and marketing of SIILTIBCY across the EU. This collaboration marks a significant milestone for the Cyrus Poonawalla Group, highlighting their commitment to delivering innovative solutions for TB infections.
Leander Grode, Managing Director of SLS Europe, commented, "The EMA’s positive opinion for SIILTIBCY represents a crucial advancement in the fight against TB. By strengthening diagnostic capabilities, we are taking significant strides toward supporting public health initiatives and aligning with global efforts to eradicate TB."
Impact on TB Control
Globally, an estimated 2 billion people are infected with TB, with 9 million new cases annually. While Europe is considered a low-incidence region, with over 170,000 TB cases annually, the large reservoir of TB infection worldwide underscores the importance of targeted testing. SIILTIBCY is poised to play a crucial role in targeted testing strategies, aligning with the WHO's End TB Strategy to further reduce the incidence of TB.
Jurgen Kwik, Chief Executive Officer of BBio, added, "By providing a reliable and precise diagnostic test, we are empowering healthcare professionals to make better-informed decisions, contain the costs of diagnosis and ultimately save more lives."
