Emcure Pharmaceuticals Gets CDSCO To Manufacture & Market the FDC Antiviral Drug
New Delhi: Granting approval for bioequivalence (BE) study and clinical trial (CT) study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to drug major Emcure Pharmaceutical to manufacture and market the antiviral combi kit of Atazanavir 300mg and Ritonavir 100mg Tablet plus Emtricitabine 200mg and Tenofovir Alafenamide 10mg Tablet for the treatment of HIV.
However, this nod is subject to the condition that the firm should conduct a post-marketing surveillance study.
This came after the drug major Emcure Pharmaceutical presented its proposal before the committee along with justification for bioequivalence (BE) study and clinical trial (CT) study waiver of the antiviral Combikit of Atazanavir 300mg and Ritonavir 100mg Tablet plus Emtricitabine 200mg and Tenofovir Alafenamide 10mg Tablet.
Atazanavir is an antiviral protease inhibitor used in combination with other antiretrovirals for the treatment of HIV. Atazanavir is extensively metabolized in humans, primarily by the liver. The major biotransformation pathways of atazanavir in humans consisted of monooxygenation and deoxygenation. Other minor biotransformation pathways for atazanavir or its metabolites consisted of glucuronidation, N-dealkylation, hydrolysis, and oxygenation with dehydrogenation. In vitro studies using human liver microsomes suggested that atazanavir is metabolized by CYP3A.
Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors. Although ritonavir was initially designed to inhibit HIV protease, studies have found that it also inhibits cytochrome P450-3A4.
The nucleoside reverse transcriptase inhibitor (NRTI) emtricitabine is used in combination with other antiretroviral therapy (ART) in the treatment of HIV-1, HIV-2, and hepatitis B virus (HBV). It is also used in combination therapy for pre-exposure prophylaxis (PrEP) to prevent HIV infection.
Tenofovir alafenamide is a nucleoside analogue reverse transcriptase inhibitor used for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease. Tenofovir alafenamide (TAF) is a prodrug of tenofovir. The antiviral properties of tenofovir are due to its inhibition of HBV polymerase, which, in turn, inhibits DNA synthesis and viral replication. TAF is indicated for the treatment of chronic hepatitis B in adults with compensated liver disease.
At the SEC meeting for Antimicrobial & Antiviral held on 25th of April 2023, the expert panel reviewed the proposal presented by Emcure Pharmaceutical regarding the antiviral Combikit of Atazanavir 300mg and Ritonavir 100mg Tablet plus Emtricitabine 200mg and Tenofovir Alafenamide 10mg Tablet.
The firm presented that FDC of Atazanavir 300mg + Ritonavir 100mg tablets is approved by CDSCO on 04.11.2008 and FDC of Emtricitabine 200mg + Tenofovir Alafenamide 10mg tablet is approved by CDSCO on 10.01.2018.
After detailed deliberation, the committee considered the request of the firm for BE study and CT study waiver and recommended the grant of permission to manufacture and market the proposed combi kit with the condition that a post-marketing surveillance study should be conducted.
In accordance with the above, the expert panel suggested that the firm should submit a post-marketing surveillance (PMS) study protocol for the proposed Combkit to CDSCO for review by the SEC.
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