Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir).
The company stated that Nirmacom is a generic version of Pfizer’s Covid-19 oral antiviral drug, Paxlovid, a SARS-CoV-2 main protease (Mpro) inhibitor.
Hetero’s Nirmacom combi-pack will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100mg (one tablet).
The company noted that the WHO has made a strong recommendation for nirmatrelvir and ritonavir to treat patients with mild and moderate Covid-19 who are at the highest risk of hospitalisation, including unvaccinated, aged or immunosuppressed people.
Hetero stated that Nirmacom will be available by prescription only and need to be started as soon as possible following Covid-19 diagnosis and within five days of symptom onset.
It intends to manufacture the drug at its facility in India.
Hetero Group of Companies managing director Dr Vamsi Krishna Bandi said: “WHO Prequalification for nirmacom is a significant milestone in the fight against Covid-19 as it allows us to expand access to this important innovative antiretroviral drug to people in need.
“We are committed to making nirmacom available faster at affordable prices across 95 LMICs including India.”
The company has signed a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) to produce and sell nirmatrelvir in LMICs.
MPP executive director Charles Gore said: “We are 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.
“With cases of Covid-19 again on the rise we need to make treatments readily available in LMICs so no one is left behind.”
Hetero has also received emergency use authorization (EUA) from the Drugs Controller General of India (DCGI) to produce and commercialise Nirmacom.