India’s Pharmaceutical company Hetero received WHO’s backing for its generic version of Covid-19 oral antiviral treatment candidate ‘Nirmatrelvir’
India’s Pharmaceutical company Hetero said it has received World Health Organization (WHO) Prequalification of medicines program (WHO PQ) approval for its generic version of Covid-19 oral antiviral treatment candidate ‘Nirmatrelvir’.
It said that it is the first prequalification for a generic version of Pfizer’s Covid oral antiviral drug ‘PAXLOVID’, which the WHO called, the best therapeutic choice for high-risk patients to date.
Hetero’s ‘Nirmacom’ (Nirmatrelvir), a generic version of Pfizer’s Covid-19 oral antiviral drug ‘PAXLOVID’ is co-packaged with ritonavir tablets.
WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate Covid-19 patients at the highest risk of hospital admissions, such as unvaccinated, aged, or immunosuppressed patients.
The combi pack, launched by Hetero as Nirmacom, will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet). It is available by prescription only and should be initiated as soon as possible after diagnosis of coronavirus and within five days of symptom onset. Nirmacom will be manufactured at Hetero’s facilities in India.
Dr. Vamsi Krishna Bandi, Managing Director, Hetero Group of Companies, said: “WHO Prequalification for Nirmacom is a significant milestone in the fight against Covid 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.”
Hetero 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 (nirmatrelvir; ritonavir), in LMICs (low- and middle-income countries).
Hetero said it has already received Emergency Use Authorisation (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market NIRMACOM. The treatment bundles two nirmatrelvir pills and one ritonavir pill and will be manufactured at Hetero’s plants in India.
Nirmatrelvir / ritonavir Side Effects
Serious side effects
Along with its needed effects, nirmatrelvir/ritonavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking nirmatrelvir / ritonavir:
- Blurred vision
- pounding in the ears
- slow or fast heartbeat
- Blistering, peeling, or loosening of the skin
- chest tightness
- clay-colored stools
- dark urine
- difficulty swallowing
- fast heartbeat
- general tiredness or weakness
- hives, itching, or skin rash
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- nausea and vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unpleasant breath odor
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting of blood
- yellow eyes and skin
Other side effects
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Change in taste
- loss of taste
- Difficulty in moving
- muscle aches, cramps, or stiffness
- swollen joints
For Healthcare Professionals
Applies to nirmatrelvir / ritonavir: oral tablet.
Common (1% to 10%): Hypertension
Common (1% to 10%): Diarrhea, vomiting
Postmarketing reports: Hypersensitivity
Common (1% to 10%): Myalgia
Common (1% to 10%): Dysgeusia, headache