Sun Pharmaceutical Industries said it has received Emergency Use Authorization or EUA from India’s Drugs Controller General of India (DCGI) to manufacture and market a generic molnupiravir in India, a week after the US-FDA gave an EUA to its use in the US.
The company has promised to make the oral drug, under the brand Molxvir, available in Indian markets “in a week’s time” and at “an affordable price”.
The drug will be used for managing CoViD-19 and has been shown to be effective in reducing fatalities and severe outcomes in COVID in trials.
It can be used for adult patients (above 18 years of age) for treating COVID if they have blood oxygen levels of over 93% and face the risk of progression of the disease including hospitalisation or death.
During the earlier waves of COVID, the only drug that was being used to manage the disease in extreme cases was remdesivir, which was being given by injection.
“Molnupiravir is an important addition to the portfolio of oral therapies available for treating Covid-19 patients,” said Sun Pharma. It said it is launching a toll-free helpline to ensure the availability of Molxvir to doctors and patients across India.
The recommended dose of the drug is 800 mg twice a day for five days.
“The duration of treatment of molnupiravir is much shorter compared to other therapies which is a significant advantage as it reduces the pill burden and enhances compliance,” the company added.
The drug should not be given to those less than 18 years of age, as it may affect bone and cartilage growth, according to the US FDA.
It should be “limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” the US-FDA had warned when it gave its nod last week.
Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from replicating.
In the US, it is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules, and should not be taken for more than five consecutive days.
US FDA also warned that molnupiravir may cause fetal harm when administered to pregnant women.
The US approval was given on the basis of a 29 day follow-up trial.
“Of the 709 people who received molnupiravir in the trial, 6.8% were hospitalized or died within this time period compared to 9.7% of the 699 people who received a placebo. Of the people who received molnupiravir one died during the follow-up period compared to nine people who received placebo. Side effects observed in the trial included diarrhea, nausea and dizziness. The safety and effectiveness of molnupiravir for the treatment of COVID-19 continue to be evaluated,” said the FDA.
The rights to the drug are held by US pharma companies Merck and Ridgeback, and Sun Pharma had signed a nonexclusive voluntary licensing agreement with them to manufacture and supply generic molnupiravir in over 100 low and middle-income countries including India.
