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Bangladeshi pharmaceutical companies Beximco and Eskayef have been given the green light to launch generic versions of US drugmaker Pfizer’s highly promising oral treatment for COVID-19.
Beximco Pharmaceuticals Limited said in a London Stock Exchange filing on Thursday that its treatment was the world’s first generic version of Pfizer's COVID-19 treatment Paxlovid -- nirmatrelvir and ritonavir tablets, co-packaged for oral use, reports bdnews24.com.
Eskayef Pharmaceuticals Limited made the same claim about its version of the antiviral drug -- nirmatrelvir tablets co-packaged with ritonavir tablets, which will be marketed under the brand name 'Paxovir'.
"Patients with mild to moderate symptoms of the coronavirus can take this medicine. It should be taken within five days of the onset of symptoms. This medicine should be taken after one tests positive for COVID," Eskayef's Executive Director Dr Mohammad Mujahidul Islam said on Thursday.
Beximco said the Directorate General of Drug Administration granted the company authorisation for emergency use of the oral antiviral drug under the brand name 'Bexovid' to treat mild to moderate COVID-19 in adults and children of 12 years and above.
Nirmatrelvir inhibits a SARS-CoV-2 enzyme to stop the virus from replicating, and ritonavir slows down nirmatrelvir's breakdown to help it remain in the body for a longer period at higher concentrations. The treatment is given as two tablets of nirmatrelvir and one tablet of ritonavir together twice a day for five days.
Bexovid will be available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of the onset of symptoms.
“It is further testament to our commitment to making affordable treatments accessible as soon as possible,” said Nazmul Hassan, managing director of Beximco Pharmaceuticals.
The oral drug, cleared by the United States Food and Drug Administration on Dec 22, could be a promising new weapon in the fight against the pandemic, as it can be taken as an early at-home treatment to help prevent COVID-19 hospitalisations and deaths.
It could also become an important tool in countries and areas with limited access to vaccines or low vaccination rates.
Data from Pfizer's clinical trial showed its antiviral regimen, Paxlovid, was 90 percent effective in preventing hospitalisations and deaths in patients at high risk of severe illness.
Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.
Pfizer announced a deal on Nov 16 to allow its promising COVID-19 treatment to be made and sold inexpensively in 95 poorer nations that are home to more than half of the world’s population.
The agreement follows a similar arrangement negotiated by Merck in October, and together the deals have the potential to vastly expand global production of two simple antiviral pills that could alter the course of the pandemic by preventing severe illness from the coronavirus.
Under the agreement, Pfizer will grant a royalty-free licence for the pill to the Medicines Patent Pool, a nonprofit backed by the United Nations, in a deal that will allow manufacturers to take out a sublicence.
They will receive Pfizer’s formula for the drug and be able to sell it for use in 95 developing countries, mostly in Africa and Asia, once regulators authorize the drug in those places.
The organisation reached a similar deal with Merck for its COVID antiviral pill, molnupiravir, to be made and sold inexpensively in 105 poorer countries.Bangladeshi companies have already begun producing and marketing generic versions of Merck’s COVID-19 pill molnupiravir.