Nirmatrelvir

Pharmaceutical company Hetero announced on December 26th that 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. This marks the first prequalification for a generic version of Pfizer's Covid-19 oral antiviral drug Paxlovid, which is co-packaged with ritonavir tablets as Nirmacom.

Nirmacom is a prescription-only drug that is recommended to be initiated as soon as possible after a Covid-19 diagnosis and within five days of symptom onset. It is manufactured at Hetero's facilities in India and will be made available at affordable prices in 95 low and medium income countries, including India.

WHO Recommendation for Nirmacom

The WHO has made a strong recommendation for the use of nirmatrelvir and ritonavir for mild and moderate Covid-19 patients at highest risk of hospital admission, such as unvaccinated, aged, or immunosuppressed patients. Hetero's Managing Director, Vamsi Krishna Bandi, stated that the WHO prequalification for Nirmacom is a significant milestone and the company is committed to making the drug available to these high-risk groups faster.

Hetero's Partnership with Medicines Patent Pool

Hetero entered into a non-exclusive voluntary licensing agreement with the Medicines Patent Pool (MPP) for the manufacturing and sale of a generic version of Pfizer's nirmatrelvir in low and middle-income countries (LMICs). MPP Executive Director Charles Gore commented on the achievement, stating, "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 sub licence agreements just nine months ago."

Emergency Use Authorization in India

Hetero has already received emergency use authorization (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market Nirmacom. This allows for the drug to be distributed and used during the Covid-19 pandemic, despite not yet completing the usual regulatory approval process.

Hetero's generic version of Pfizer's Covid-19 antiviral treatment, Nirmacom, has received WHO prequalification, marking the first approval for a generic version of Paxlovid. The drug is recommended for use in mild and moderate Covid-19 patients at highest risk of hospitalization, such as unvaccinated, aged, or immunosuppressed individuals. Hetero is committed to making Nirmacom available at affordable prices in 95 low and medium income countries, including India, where it has already received emergency use authorization.

Written by princy

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