Hyderabad-based Hetero’s Covid-19 oral drug Nirmacom gets WHO prequalification

Hetero’s combi pack, known as Nirmacom, will contain Nirmatrelvir 150 mg and Ritonavir 100mg, and should be given within five days of symptom onset.

BySouth First Desk

Published Dec 26, 2022 | 1:38 PMUpdatedDec 26, 2022 | 1:48 PM

Hetero Covid19 Nirmacom

Nirmatrelvir developed by Hetero has received the approval of the World Health Organisation Prequalification of Medicines Programme, the Hyderabad-based pharmaceutical firm announced on Monday, 26 December.

Nirmatrelvis is a generic version of the Covid-19 oral anti-viral drug. Hetero’s combi pack, Nirmacom, contains Nirmatrelvir 150 mg (2 tablets) and Ritonavir 100mg (1 tablet).

It is a prescription-only pack and should be initiated as soon as possible after a diagnosis of Covid-19 and within five days of symptom onset.

Nirmacom will be manufactured at Hetero’s facilities in India.

Hetero said in a statement that it is the first prequalification for a generic version of Pfizer’s Covid-19 oral anti-viral drug ‘Paxlovid,’ which, the WHO termed the best therapeutic choice for high-risk patients to date.

WHO strongly recommended Nirmatrelvir and Ritonavir for mild and moderate Covid-19 patients at the highest risk of hospital admission, such as unvaccinated, aged or immunosuppressed patients.

“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,” Vamsi Krishna Bandi, Managing Director, Hetero Group of Companies, said.

Hetero entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) for the manufacturing and sale of a generic version of Pfizer’s Covid-19 oral anti-viral treatment candidate Nirmatrelvir, which is co-packaged with Ritonavir (Nirmatrelvir; Ritonavir), in LMICs.

Charles Gore, Executive Director of MPP, said: “We are delighted to see the first generic version of Nirmatrelvir under MPP licence with Pfizer, receive quality assurance approval from WHO. With cases of Covid-19 again on the rise, we need to make treatments readily available in LMICs so no one is left behind.”

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

Also read: Covid surge: No need to panic, says top virologist

CDSCO approval for Paxlovid

Another Hyderabad-based Zenara Pharma, a subsidiary owned by Biophore India Pharmaceuticals, has received emergency-use authorization from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market in India a generic version of Pfizer’s Covid-19 pill Paxlovid for the treatment of patients with mild symptoms of the disease.

Related: Read all about Covid-19 booster dose

Paxlovid rebound

It should be noted a study found, that Nirmatrelvir and Ritonavir tablets reduced the risk of hospitalisation or death by 89 percent among patients who were unvaccinated and not hospitalised.

Also, there are cases of Paxlovid rebound– a person who has taken the antiviral drug Paxlovid, recovers — but tests positive again after two to eight days of recovery. Even US president Joe Biden suffered from Paxlovid rebound.

(With PTI inputs)