Glenmark Pharmaceuticals has launched FabiFlu, a brand of Favipiravir, an antiviral drug to treat COVID-19 after receiving approval from the Drugs Controller General of India (DCGI) on Saturday, June 20. This is the first drug to be orally administered for treating COVID-19 in India.
The drug is claimed to reduce the viral load of people with mild and moderate symptoms in four days. FabiFlu was launched on the day India reported over 14,000 cases, the highest one-day rise it has witnessed since the first cases in January, 2020.
The company received approval for manufacturing and marketing of the drug. Glenmark had received permissions to begin clinical trials for the drug on April 30, 2020.
Glenmark's Role In Favipiravir Production
Glenmark in a press release stated that the drug can be used for people across all age groups above 20 years of age and can also be orally administered to patients living with other co-morbidities such as diabetes and hypertension.
The drug reduces the viral load of SARS-CoV-2 within 4 days and provides faster symptomatic improvement. The company has further emphasised that the drug has shown clinical improvement in 88% of COVID-19 cases with mild and moderate symptoms.
The company is pricing the drug at Rs 103 /tablet which will only be sold when prescribed by a doctor, with its recommended dose being 1800 mg twice on day 1, followed by 800 mg twice daily up to day 14.
According to the CEO Glen Saldanha, "Glenmark will work closely with the government and medical community to make FabiFlu® quickly accessible to patients across the country."
The company began its Phase 3 clinical trials on May 12, 2020 with nine hospitals and 150 patients on a randomized basis. The treatment is to be administered for a maximum of 14 days and the results of which were expected in July.
The pharmaceutical developed its own Active Pharmaceutical Ingredient (API) and its formulation through its in-house Research and Development Team in India. The drug controller body then permitted the company to begin its clinical trials on April 30, 2020.
Glenmark is currently conducting a Phase 3 trial of a combination of Favipiravir with Umifenovir. The other drug acts as a viral entry inhibitor. This trial is called the Favipiravir and Umifenovir Trial in Indian Hospital Setting (FAITH) Trial.
What Is Favipiravir?
Favipiravir, an antiviral drug is sold under the brand name Avigan in Japan. It has earlier been used against Ebola. The antiviral stops the virus from replicating in the body, and in turn reducing the amount of the virus making it non-infectious.
The drug has been approved in Italy, Japan, China, and Russia for treating COVID-19.
In two clinical trials conducted in Wuhan and Shenzhen, this drug was seen to act against SARS-CoV-2 while in February, director of China's National Centre for Biotechnological Development recommended the use of this anti-viral.
The Japanese study, however, started to use Favipiravir on compassionate grounds and only provided it to hospitals that participated in the observational study after seeking an informed consent by the patients.
Currently, the World Health Organization (WHO) is conducting the Solidarity Trial for checking the efficiency of anti-HIV drugs lopinavir and ritonavir, remdesivir, and plasma therapy against COVID-19. The WHO stopped the hydroxychloroquine (HCQ) trial after a study by Oxford University showed that HCQ had no effect on SARS-CoV-2.
This Oxford study called the RECOVERY Trial also found that a low-costing c orticosteroid, Dexamethasone was found to reduce COVID-19 deaths by one/third and one/fifth in ventilated and oxygenated patients respectively.
India has been actively following the plasma therapy at selected hospitals while also using a combination of drugs to treat COVID-19 patients.
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