Nirmacom by Hetero will contain 150 mg nirmatrelvir (2 tablets) and 100 mg ritonavir (1 tablet). A patient will pay about $4,900 for the full course, an industry source said, adding that it will initially be sold only to hospitals and government agencies. According to the source, the treatment is estimated to cost about $70 per patient in low- and middle-income countries (LMIC).
Who should buy Nirmacom?
WHO strongly recommends nirmatrelvir and ritonavir for mild to moderate COVID-19 individuals at high risk of hospitalization, such as those who are unvaccinated, elderly, or immunocompromised.
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The Medicines Patent Pool (MPP) announced in March that Pfizer had signed agreements with 35 companies (including 19 from India) to manufacture a generic version of Paxlovid for LMICs at a lower cost.
Nirmacom Usage Guidelines
The drug will be available by prescription and should be started as soon as possible after a diagnosis of COVID-19 and within five days of the onset of symptoms. According to the company, Nirmacom will be manufactured at Hetero’s facilities in India.
Vamsi Krishna Bandi, Managing Director, Hetero Group of Companies, said: “The WHO Pre-Qualification for Nirmacom is an important milestone in the fight against COVID-19 as it allows us to expand access to this important innovative antiretroviral drug for people in need. We are in 95 LMICs, including India also committed to acquiring Nirmacom faster at affordable prices.”
Charles Gore, CEO of MPP, said: “We are pleased to see the first generic version of nirmatrelvir under MPP license with Pfizer receive quality assurance approval from the WHO. This is an impressive achievement for Hetero as we announced the sub-licensing agreements nine months ago. . We need easy access to treatments in LMICs so that no one is left behind as cases of COVID-19 rise again.”
DCGI Approves Manufacture and Distribution of Nirmacom
The Drug Controller General of India (DCGI) had earlier granted Emergency Use Authorization (EUA) to Hetero to manufacture and distribute Nirmacom.
Source: Medium