Zydus Gets CDSCO Panel Nod To Manufacture Market Letermovir 240 mg, 480 mg Tablet

New Delhi: The drug major Zydus has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Letermovir 240 mg and 480 mg tablets with Phase-III clinical trial waiver.

However, this nod is subject to the condition that Zydus should submit the Phase-IV clinical trial (CT) protocol to CDSCO within three months of the grant of permission.

Furthermore, the expert panel suggested that the drug product be sold on the prescription of specialists in organ transplant, infectious disease, hematologist, etc.

This came after Zydus presented the proposal for a grant of permission to manufacture and market Letermovir tablets 240mg and 480 mg with a Phase-III clinical trial waiver request, along with a bioequivalence (BE) study report.

Letermovir is an antiviral medication used for prophylaxis in adult transplant recipients at risk of cytomegalovirus (CMV) infection and disease.

Letermovir is indicated for prophylaxis against cytomegalovirus (CMV) infection and disease in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT) who are CMV-seropositive. It is also indicated for prophylaxis against CMV disease in adult kidney transplant recipients who are at risk (i.e. donor CMV-seropositive/recipient CMV-seronegative).

Letermovir is a viral terminase inhibitor. It specifically inhibits the CMV viral terminase complex which is encoded by the CMV genes UL56, UL51, and UL89. This inhibition has the effect of preventing cleavage of CMV DNA concatamers, resulting in long-uncleaved DNA and noninfectious viral particles.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal presented by the drug major Zydus for the approval to manufacture and market the drug Letermovir.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Letermovir tablets 240mg and 480 mg in the country with the following conditions:

i) The firm shall submit Phase-IV CT protocol to CDSCO within three months of grant of permission.

ii) The drug product to be sold on prescription of specialists in organ transplant, infectious disease, hematologist, etc.

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