WHO made a strong recommendation for Nirmatrelvir and Ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission.
Pharmaceutical company Hetero on December 26 said it has received World Health Organization Prequalification of Medicines Programme (WHO PQ) approval for its generic version of Covid-19 oral antiviral treatment candidate nirmatrelvir.
Nirmatrelvir, which originated in Pfizer laboratories, is co-packaged with ritonavir tablets as Pfizer’s Covid-19 oral antiviral drug Paxlovid. This is the first prequalification for a generic version of Paxlovid, Hetero said.
The combi pack launched by Hetero as Nirmacom will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100 mg (one tablet). A prescription only drug that the company said be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset, Nirmacom is be manufactured at Hetero’s facilities in the country.
WHO had made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate Covid-19 patients at highest risk of hospital admission, such as unvaccinated, aged or immunosuppressed patients, Hetero said in a release.
Managing Director of Hetero Group of Companies Vamsi Krishna Bandi said WHO prequalification for Nirmacom is a significant milestone and the company is committed to making the drug available faster at affordable prices across 95 low and medium income countries, including India. Hetero was among a clutch of companies that entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) for manufacturing and sale of a generic version of Pfizer’s nirmatrelvir in LMICs.
“Delighted to see the first generic version of nirmatrelvir under MPP license with Pfizer receive quality assurance approval from WHO. This is an impressive achievement from Hetero as we announced the sublicence agreements just nine months ago,” MPP Executive Director Charles Gore said.
Hetero has already received emergency use authorisation (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market Nirmacom.
thehindu.com