Pharmaceutical company Hetero announced on Monday, December 26, that it has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its generic version of COVID-19 oral antiviral treatment candidate nirmatrelvir. This is the first prequalification for a generic version of Pfizer's COVID-19 oral antiviral drug Paxlovid, according to Hetero. WHO has recommended nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at the highest risk of hospital admission, such as unvaccinated, aged, or immunosuppressed patients.
The combi pack, launched by Hetero as Nirmacom, will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100mg (one tablet). “It is available by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset. Nirmacom will be manufactured at Hetero's facilities in India,” said a press release from Hetero.
Hetero said it has entered into a non-exclusive voluntary licensing agreement with the international organisation Medicines Patent Pool (MPP) for the manufacturing and sale of a generic version of nirmatrelvir, which is co-packaged with ritonavir, in low and middle-income countries.