Published date: 30-Dec-2021
Source: The Daily Star

Eskayef launches first US FDA-approved oral Covid medicine in Bangladesh

Source: The Daily Star

Eskayef Pharmaceuticals Limited, one of the leading drug manufacturing companies of Bangladesh, has received emergency use authorisation for a novel oral antiviral medicine for the treatment of Covid-19 -- world's 1st generic version of Nirmatrelvir tablets co-packaged with Ritonavir tablets -- with the brand name "Paxovir". The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for Nirmatrelvir tablets and Ritonavir tablets, co-packaged for oral use for the treatment of mild-to-moderate Covid-19 in adults and paediatric patients over 12 years of age. Eskayef is manufacturing Paxovir from its state-of-the-art manufacturing facility, which is approved by UKMHRA, TGA Australia and EU GMP. After completing all development procedures, Eskayef has received emergency use authorisation from the Directorate General of Drug Administration (DGDA) of Bangladesh.

Simeen Rahman, Managing Director and CEO of Eskayef Pharmaceuticals Limited, said, "When the entire world is waiting for an oral anti-Covid medicine with higher success rate, we are pleased to launch Paxovir as the world's first generic Nirmatrelvir and Ritonavir combination for the people of Bangladesh and across the world." "Ensuring every possible treatment option against Covid-19 is core to our purpose of serving the humanity during this darkest era of the century. This promising new treatment option is definitely a significant step in fighting the battle against Covid-19," she added.

Paxovir is indicated for treatment of mild-to-moderate Covid-19 with positive results of direct SARS-CoV-2 viral testing, and patients at high risk for progression to severe Covid-19, including hospitalisation or death. The results from a clinical trial involving more than 2,200 people at high risk for developing serious Covid-19 found Nirmatrelvir and Ritonavir tablets reduced the risk of hospitalisation or death by 89%, compared with a placebo, when taken within three days of first symptoms of illness. When taken within five days, the drug reduced the risk of hospitalisation and death by 88%. Eskayef took the same approach in case of Remivir, the world's first generic Remdesivir brand, which was launched immediately after US FDA approval. The company launched world's first generic Molnupiravir with the brand name "Monuvir" just within 4 days of its emergency use authorisation by UK MHRA. Eskayef Pharmaceuticals Limited is one of the organisations of Transcom group, founded by Latifur Rahman. Eskayef has been producing medicines for 31 years and currently exporting its medicines to 65 countries across the world.