Paxlovid is administered to COVID-19 patients who have mild to moderate symptoms and are at high risk of hospitalization.
Highlights:
Hetero said that its generic version of Pfizer’s COVID-19 oral antiviral therapy candidate nirmatrelvir has acquired World Health Organization (WHO) prequalification approval.
“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,” a note from Hetero said.
- Nirmatrelvir and Ritonavir are strongly recommended by the World Health Organization (WHO) for mild and intermediate COVID-19 individuals at high risk of hospitalization
- A generic version of Pfizer’s COVID-19 oral antiviral medicine Paxlovid containing nirmatrelvir has received WHO preapproval
- The newly approved Hetero’s Nirmacom combo pack will include Nirmatrelvir and Ritonavir tablets
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‘Hetero Pharmaceutical’s generic version of COVID-19 oral antiviral therapy candidate ‘Nirmatrelvir’ has gained World Health Organization Prequalification of pharmaceuticals program (WHO PQ) approval. In India, the complete course will cost $60, or almost Rs 5,000.’
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Composition and Pricing of Nirmacom
Nirmacom by Hetero will comprise nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet). A patient would pay roughly $4,900 for the full course, according to an industry source, who added that it would first be sold solely to hospitals and government institutions. The treatment is estimated to cost around $70 to a patient in low and middle-income countries (LMIC), according to the source.Advertisement
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Who should take Nirmacom
WHO strongly recommends nirmatrelvir and ritonavir for mild and moderate COVID-19 individuals who are at high risk of hospitalization, such as those who are unvaccinated, elderly, or immunocompromised.The Medicines Patent Pool (MPP) announced in March that it has struck agreements with 35 companies (including 19 from India) to produce a generic version of Pfizer’s Paxlovid at a lower cost for LMICs.
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Guidelines for Nirmacom Usage
The medication will be available by prescription and should be started as soon as feasible following the diagnosis of COVID-19 and within five days of the onset of symptoms. Nirmacom will be manufactured in Hetero’s facilities in India, according to the company.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.”
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 sub-license 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.”
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DCGI Approves Manufacturing and Distribution of Nirmacom
The Drugs Controller General of India (DCGI) has previously granted Hetero an Emergency Use Authorization (EUA) to manufacture and distribute Nirmacom.Source-Medindia
