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MUMBAI: Japanese pharma firm Shionogi and Medicines Patent Pool (MPP), a UN-backed public health organisation, announced that they have signed seven sub-licence agreements for the former’s Covid-19 once-daily anti-viral pill, ensitrelvir.
Of these, two Indian generic companies, Hetero and Laurus Labs, have signed agreements to produce generic versions of the oral drug to increase its access in developing countries, said a statement.
Ensitrelvir, known as Xocova in Japan, recently received emergency regulatory approval from the Ministry of Health, Labour and Welfare for the treatment of SARS-CoV-2 infection. In April, ensitrelvir was granted fast track designation by the US Food and Drug Administration. FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfil an unmet medical need.
Ensitrelvir is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
The oral antiviral is currently approved in Japan and being evaluated in clinical trials outside the country.
Under the terms, the seven generic manufacturers will be able to manufacture and supply ensitrelvir in 117 low- and middle-income countries (LMICs), pending regulatory authorisation or approval in those countries. Others include, three generic manufacturing companies from China: Zhejiang Charioteer Pharmaceutical Co, Zhejiang Lepu Pharmaceutical Co, and Fosun International, Ukrainian company Joint Stock Company Lekhim, and Vietnamese company Stellapharm JV Co.
Charles Gore, executive director of MPP, said: “Even though COVID-19 is no longer classified as a Public Health Emergency of International Concern, we see numbers ebb and flow across continents as we learn to live with the disease. So having quality effective treatments readily available in LMICs is still so important.”
Of these, two Indian generic companies, Hetero and Laurus Labs, have signed agreements to produce generic versions of the oral drug to increase its access in developing countries, said a statement.
Ensitrelvir, known as Xocova in Japan, recently received emergency regulatory approval from the Ministry of Health, Labour and Welfare for the treatment of SARS-CoV-2 infection. In April, ensitrelvir was granted fast track designation by the US Food and Drug Administration. FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfil an unmet medical need.
Ensitrelvir is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
The oral antiviral is currently approved in Japan and being evaluated in clinical trials outside the country.
Under the terms, the seven generic manufacturers will be able to manufacture and supply ensitrelvir in 117 low- and middle-income countries (LMICs), pending regulatory authorisation or approval in those countries. Others include, three generic manufacturing companies from China: Zhejiang Charioteer Pharmaceutical Co, Zhejiang Lepu Pharmaceutical Co, and Fosun International, Ukrainian company Joint Stock Company Lekhim, and Vietnamese company Stellapharm JV Co.
Charles Gore, executive director of MPP, said: “Even though COVID-19 is no longer classified as a Public Health Emergency of International Concern, we see numbers ebb and flow across continents as we learn to live with the disease. So having quality effective treatments readily available in LMICs is still so important.”
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