CHMP positive for Siiltibcy for the diagnosis of Mycobacterium tuberculosis infection
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Siiltibcy, intended for the diagnosis of Mycobacterium tuberculosis infection. The applicant for this medicinal product is Serum Life Science Europe GmbH
Siiltibcy will be available as a solution for injection containing 0.5 µg/ml rdESAT-6 and 0.5 µg/ml rCFP-10. The active substances of Siiltibcy are Mycobacterium tuberculosis derived antigens (rdESAT‑6 and rCFP‑10). The intradermal presentation of the antigens to the immune system induces a delayed‑type hypersensitivity reaction in people carrying the bacteria, seen as an induration at the site of injection.
The diagnostic performance of Siiltibcy (sensitivity and specificity) was compared to two products intended for the diagnosis of Mycobacterium tuberculosis: Quantiferon TB Gold In-Tube test (QFT, an in vitro test) and Tuberculin purified derivative (PPD RT23, a test used intradermally like Siiltibcy). In comparison to QFT, Siiltibcy is easier to use. When compared to PPD RT23, Siiltibcy has a slightly lower sensitivity but the advantage of a higher specificity in Bacillus Calmette-Guérin-vaccinated people and gives fewer false positives as it better excludes people infected by mycobacteria other than Mycobacterium tuberculosis. The most common side effects with Siiltibcy are pruritus, pain and hematoma at the site of injection.
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