India-based Hetero’s Covid-19 oral drug Nirmacom gets WHO backing

India's Pharmaceutical company Hetero said it has received World Health Organization (WHO) Prequalification of medicines program (WHO PQ) approval for its generic version of Covid-19 oral antiviral treatment candidate 'Nirmatrelvir'.

It said that it is the first prequalification for a generic version of Pfizer's Covid oral antiviral drug 'PAXLOVID', which the WHO called, the best therapeutic choice for high-risk patients to date.

Hetero's 'Nirmacom' (Nirmatrelvir), a generic version of Pfizer's Covid-19 oral antiviral drug 'PAXLOVID' is co-packaged with ritonavir tablets.

WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate Covid-19 patients at the highest risk of hospital admissions, 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 coronavirus 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 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 (low- and middle-income countries).

Hetero said it has already received Emergency Use Authorisation (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market NIRMACOM. The treatment bundles two nirmatrelvir pills and one ritonavir pill and will be manufactured at Hetero's plants in India.