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A Subject Expert Committee (SEC), advising the drug regulator on various approval related technical matters, has sought Serum Institute of India (SII) and the country’s apex medical research body Indian Council of Medical Research (ICMR) to present a combined view on the approval of the former’s tuberculosis (TB) testing product C-Tb and the latter’s request to extend the trial for additional clinical trial in population less than 18 years of age.
In a recent meeting of the SEC for antimicrobial and antiviral segments, the ICMR has recommended use of the new test among the adult population under the National TB Elimination Programme (NTEP). The test is claimed to have abilities to identify those who are infected with TB and at risk of developing active disease.
ICMR has presented its clinical study data on C-Tb, along with the recommendations of ICMR expert group on the study conducted with the product, manufactured by Danish firm Statens Serum Institut (SSI). SSI has entered into a partnership with SII in October, 2019, under which the latter will be producing and distributing the test.
It said that the C-Tb has shown a similar safety profile as that of the Purified Protein Derivative (PPD) test and is safe in the Indian population at 48-72 hours and at 28 days. It has shown overall better sensitivity in general population and household contacts or high risk population of TB patients as compared to PPD, while specificity was comparable in both groups in detecting latent TB taking Interferon-Gamma Release Assays (IGRAs) as the reference standard.
“C-Tb can be used for detection of latent-TB under the NTEP for population 18 years and above. More data needs to be generated in less than 18 years of age,” it recommended.
“Lack of availability of PPD necessitates use of C-Tb which is more sensitive than PPD from a programmatic point of view,” it added.
ICMR also requested for extension of the trial on additional 400 subjects less than 18 years of age as per the initial approved protocol.
Meanwhile, SII has submitted its proposal for manufacturing and marketing of the C-Tb along with the published clinical study data, conducted in other countries along with comparability data in respect of manufacturing details, analytical and release profile. Product characterisation, stability study data etc., including drug substances, product manufactured at SII and SSI, Denmark.
The company informed the Committee that the product will be manufactured by SII, using the same technology as Statens Serum Institut, Denmark.
Considering both the requests, the Committee said, “After detailed deliberation and varying requests from ICMR & SII, the committee recommended that SII and ICMR should deliberate the matter amongst themselves and present the combined view with regards to the application for approval of the product of SII in adult population and proposal to conduct clinical trial in additional subjects including the population less than 18 years for further consideration by the Committee”.
SSC, while announcing its partnership with SII in 2019, said that the current test – the Tuberculin test, or the Mantoux test, - often shows a positive result when used to test persons who are not infected with TB, but who have been vaccinated against the disease with the traditional BCG vaccine (Bacillus Calmette-Guéring).
C-Tb is a modern version of the Tuberculin test. It has the advantage, among others, that the diagnosis of TB infection is reliable, regardless of whether the tested person has been BCG-vaccinated or not.
“The new test makes it possible for the very first time to determine with certainty, in a very simple way, whether a person is infected with TB or not, and in this way target preventive treatment”, said Peter Lawaetz Andersen, research director for vaccines at SSI. Production of the test is expected to take place in SII’s high-tech facilities in Pune, India.
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