Hetero emerges first to get WHO Prequalification for Covid drug Nirmacom

NEW DELHI: Pharmaceuticals firm Hetero on Monday said it has received World Health Organisation Prequalification of medicines program (WHO PQ) approval for its generic version of COVID-19 oral antiviral treatment candidate 'Nirmatrelvir'. It is priced $60 or nearly Rs 5,000 for full course in India.

Hetero's 'NIRMACOM' (Nirmatrelvir), a generic version of Pfizer's COVID-19 oral antiviral drug 'PAXLOVID', is co-packaged with ritonavir tablets, the company said in a statement.

"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 (low- and middle-income countries) including India," Hetero Group of Companies Managing Director Vamsi Krishna Bandi said.

Hetero said it had 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 in LMICs.

"We are delighted to see the first generic version of nirmatrelvir under MPP license with Pfizer, receive quality assurance approval from WHO," MPP Executive Director Charles Gore said.

He further said, "This is an impressive achievement from Hetero as we announced the sub-licence 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."

NIRMACOM will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet), it added.

"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," the company said.

Hetero said it has already received Emergency Use Authorisation (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market NIRMACOM.