Beximco get DGDA’s marketing authorisation for Covid-19 pill molnupiravir
The Directorate General of Drug Administration (DGDA) has issued marketing authorisation for the first-ever Covid-19 pill molnupiravir to two pharmaceutical companies in the country.
The companies are Eskayef Pharmaceuticals Ltd and Beximco Pharmaceuticals Ltd.
Major General Mahbubur Rahman, director general of DGDA, confirmed the development to journalists during a briefing this noon.
The medicine which can reduce deaths and hospital admission of Covid-19 patients by 50 percent is now available in the market and can be used as per doctors’ prescription.
There are eight other companies which are waiting to get marketing authorisation, the DGDA director general said.
A number of top local pharmaceutical companies applied for the recipe approval of DGDA after the process to produce molnupiravir, developed by US drug companies Merck and the Ridgeback Biotherapeutics, began in Bangladesh.
DGDA already gave the approval to some companies. Others will get it too.
Following the recipe approval, local pharmaceutical companies will produce samples and submit them to the DGDA. If allowed by the drug authorities, the companies can supply the pill to the market.
Experts observed this as an important progress in the fight against the Covid-19 pandemic.
Molnupiravir, the first and only specific drug developed to treat Covid-19 patients, will be given twice a day to vulnerable patients diagnosed with the disease.
In clinical trials of the pill, originally developed to treat flu, the risk of hospitalisation or death was cut by about 50 percent and during the trials only 7.3 percent of the patients who were given this medicine needed to be hospitalised.
The trials were done in 23 countries, including the UK, US, Canada, France, Germany, Japan and the Philippines.
On November 4, the United Kingdom Medicine and Healthcare Products Regulatory Authority (UK-MHPRA) approved the medicine for therapeutic use.
Meanwhile, the European Medicine Agency and the Food and Drug Administration of the US are considering approval.
While a number of foreign pharmaceuticals have been trying to develop medicines to treat Covid-19, Merck and the Ridgeback Biotherapeutics have come ahead in the race. Another drug developed by the Pfizer company has also shown promising results in preliminary trials, reports global media.
Medicine experts observed the initiative to produce Covid-19 drug locally as an important event.