SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug
The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and Dohme (MSD), which is the originator of the drug, has also supported the application of Emcure Pharmaceuticals for manufacturing and marketing of the drug and its bulk drug, under an exclusive agreement, to accelerate its availability in the country.MSD, along with Emcure Pharmaceuticals presented their proposal for phase III clinical trial waiver with the drug before the SEC and the committee recommended the clinical trial waiver in its recent meeting held in New Delhi, subject to certain conditions.Doravirine 100 mg is MSD’s oral non-nucleoside reverse transcriptase inhibitor (NNRTI) drug indicated for the treatment of HIV-1 infection in adults. Merck offers doravirine as the single entity tablet under the brand Pifeltro, and as used in combination with other antiretrovirals (ARVs), and in the fixed dose combination tablet under the brand Delstrigo (doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg).Emcure has been granted permission to conduct bioequivalence study in August, 2022 and MSD has presented the safety and efficacy data from the phase III clinical studies it has conducted earlier with the drug, as part of the process.MSD has also presented non-clinical toxicity data including genotoxicity, carcinogenicity, antigenicity, immunotoxicity, or dependence, reproductive and development toxicology data before the expert committee in the country for the approval. The Committee observed that Doravirine tablet for oral use is approved in more than 70 countries including USA, European Union, Japan, United Kingdom, Australia, and Canada and the fixed dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate tablet is approved in more than 65 countries including USA and in Europe, Middle East, and Africa (EMEA).The Committee also observed that there is an unmet need for the drug in the country, “and hence recommended for the grant of Phase III clinical trial waiver to support application of Emcure Pharmaceutical for manufacturing, marketing permission of doravirine tablet 100 mg and doravirine bulk drug,” subject to conditions.The conditions include that Emcure should submit the BE study report before the committee, and should conduct Phase IV clinical trial study for which the firm should submit phase IV clinical trial protocol within three months of approval.Emcure should also submit pharmaceutical equivalence data with the innovator product Pifeltro. MSD should submit the Chemistry Manufacturing Control (CMC) data to support the pharmaceutical equivalence with Emcure’s doravirine tablet 100 mg and bulk drug. It also recommended that the proposed indication should be that the drug is “indicated in combination with other antiretroviral agents for treatment of HIV-1 infection in adults and paediatric patients weighing at least 35 kg with no prior antiretroviral treatment history only,” which means treatment naive patients.MSD has earlier announced that it has entered into agreement with generic manufacturers to provide license for manufacturing and distribution of generic doravirine and its combination drugs in several countries as part of its efforts to increase access of the medicine among the underserved population.In September, 2022, the company announced that it has entered into non-exclusive voluntary licensing agreements with two leading generic manufacturers for the drug, without revealing the name of the manufacturers. It said that under the agreement, Merck will provide licenses for the registration, commercialization, and distribution of generic doravirine (100 mg) for use in a single entity tablet and in a fixed-dose combination tablet with lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) in 86 countries, including all countries of sub-Saharan Africa, other low- and lower middle-income countries outside of sub-Saharan Africa (as classified by the World Bank), and all Least Developed countries (as defined by the United Nations). Nearly 80% of people living with HIV globally reside in these 86 countries, it added.
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