- The drug is approved or under emergency use authorization for COVID-19 in many countries, including the US, UK, EU, Singapore, Australia, Japan and China.
- We reiterate our commitment to make affordable innovations available to the last man in society: Dr Rajiv Modi, CMD, Cadila Pharmaceuticals.
NE BUSINESS BUREAU
AHMEDABAD, MARCH 18
Pharma major, Cadila Pharmaceuticals on Thursday announced that it has received a licence to manufacture a generic version of Pfizer’s oral antiviral Covid-19 medication – nirmatrelvir,through a license from Medicines Patent Pool (MPP), an UN-based public health organisation working to increase access to life-saving medicines for low- and middle-income countries.
“We are pleased to partner with MPP.to make a generic version of the innovative medicine PAXLOVID for the global community and contribute towards reducing the health burden due to the pandemic. We reiterate our commitment to make affordable innovations available to the last man in society,” said Dr Rajiv Modi, CMD, Cadila Pharmaceuticals.
Cadila will cater to Indian and export markets since many countries with high COVID 19 burden lack access to effective therapy. The U.S. Food and Drug Administration (FDA) was the first regulatory agency to authorise the use of PAXLOVID, nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use to treat high-risk mild-to-moderate Covid-19 adults and paediatric patients above 12 years of age weighing at least 40 kg.
Pfizer’s PAXLOVID consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. PAXLOVID is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for 30 tablets. The drug is available by prescription only and should be initiated as soon as possible after the diagnosis of Covid-19 and within five days of symptom onset.
The FDA granted the emergency use authorisation to PAXLOVID based on clinical data from Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients) trial, which enrolled non-hospitalised adults aged 18 and older with confirmed Covid-19 at increased risk of progressing to severe illness. The data showed an 89% reduction in the risk of Covid-19 related hospitalisation or death from any cause in adults treated with PAXLOVID, compared to placebo, within three days of symptom onset (primary endpoint).
Meanwhile, the Medicines Patent Pool (MPP) announced on Thursday that it has signed agreements with 35 companies to manufacture the generic version of Pfizer’s oral Covid-19 treatment nirmatrelvir, which in combination with a low dose of ritonavir can be supplied in 95 low- and middle-income countries.
This includes 19 Indian drug makers like Torrent Pharma, Cadila Pharma, Hetero, Biocon, Strides, Glenmark, Emcure, Granules, Macleods, Sun Pharma, and Cipla among others.
