Hetero, India’s leading pharmaceutical company with the widest global reach, announced the receipt of 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’, which the WHO called, the best therapeutic choice for high-risk patients to date.
WHO 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.
The combi pack, launched by Hetero as NIRMACOM, will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet). It is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. NIRMACOM will be manufactured at Hetero’s facilities in India.
Dr. Vamsi Krishna Bandi, Managing Director, Hetero Group of Companies, 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.”
Hetero entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) for manufacturing and sale of a generic version of Pfizer’s COVID-19 oral antiviral treatment candidate nirmatrelvir, which is co-packaged with ritonavir (nirmatrelvir; ritonavir), in LMICs.
Charles Gore, Executive Director of MPP 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 already received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market NIRMACOM.