On Wednesday, Pfizer received the US Food & Drug Administration’s emergency-use authorisation for Paxlovid, its Covid-19 antiviral treatment. The treatment can be used in both high-risk adults and paediatric patients over 12 years and weighing at least 40 kg. The development is likely to result in several Indian manufacturers beginning generic production of the anti-viral pill.
What is Paxlovid?
PF-07321332, Pfizer’s antiviral Covid-19 treatment candidate, is administered in combination with a low dose of HIV medicine Ritonavir.
On Wednesday, the US pharma giant received emergency-use authorisation based on clinical data that showed it reduced risk of hospitalisation or death by 89% within three days of the symptoms’ onset and 88% within five days of onset when compared to the placebo group.
Significantly, the European Medicines Agency issued an advisory that Paxlovid could treat adults with Covid-19 who did not require supplemental oxygen supply and who were at increased risk of progressing to severe disease.
Indian companies manufacturing Pfizer’s drug
Several Indian drug manufacturers are chalking out plans to manufacture Paxlovid’s generic version. Indian pharma giants Sun Pharmaceutical Industries, Optimus Pharma, and Dr Reddy’s Laboratories are exploring the possibility of manufacturing the pill, reports suggest.
The process of manufacturing Paxlovid generic
Pfizer announced a deal with the United Nations-backed Medicines Patent Pool, a public health organisation, on November 16. As part of the deal, it signed a voluntary licence agreement for Paxlovid. The agreement will facilitate the production and distribution of the oral antiviral treatment candidate by granting sub-licences to qualified generic manufacturers.
Pfizer expects Paxlovid will reach 95 countries as part of the agreement, covering approximately 53% of the global population. This will include low- and lower-middle-income countries and a few upper-middle-income countries such as India.
The company will not receive any royalty on sales in low-income countries. Pfizer will further waive royalties on sales in countries covered by the agreement while Covid-19 remains a Public Health Emergency of International Concern, as classified by the World Health Organization.
Indian manufacturers will have to sign an agreement as part of this deal to manufacture a generic version of Paxlovid.
Clinical trials by Indian drug manufacturers
The Indian generic drug manufacturing companies will be asked to conduct late Phase III trials on Indian participants. The trials will likely be on the lines of the clinical trials Molnupiravir, Merck’s Covid-19 antiviral drug.
Cipla, Dr Reddy’s Laboratories, Sun Pharmaceutical Industries, Emcure Pharmaceuticals, and Torrent Pharmaceuticals announced that they were collaborating for Molnupiravir’s trial for the treatment of mild Covid-19 in outpatient settings.
from The Financial Express https://ift.tt/3EpjhlC
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