Mumbai based firm, Glenmark Pharmaceuticals on Saturday launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients suffering with mild to moderate Covid-19.
Glenmark received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) on Friday.
The company gave a statement where it claimed FabiFlu is the first oral Favipiravir-approved medication for the treatment of Covid-19.
“This approval comes at a time when cases in India are spiralling like never before, putting a tremendous pressure on our healthcare system,” Glenmark Pharmaceuticals Chairman and ManagingDirector Glenn Saldanha said.
Saldhana also added saying that the company hopes availability of this drug will facilitate effective treatment for Civic-19 and in such grave times FabiFlu will offer patients in India a much needed and timely therapy option.
As per Suldhana, Fabiflu has shown encouraging success against Civic-19 in mild to moderate infected patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications, he noted.
“Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country,” Saldanha said.
The drug will be made available as a prescription based medication. Citizens will need a prescription to buy the drug. The drug will cost Rs103 per tablet.
The recommended dose is 1,800 mg twice on the first day of consumption followed by 800 mg twice daily for the next 14 days.
Favipiravir can be used by people with mild to moderate Covid-19 symptoms who also suffer from conditions such as diabetes and heart disease.
Glenn also added that the drug offers rapid reduction in viral load within four days and provides faster symptomatic and radiological improvement.
The drug showed 88 per cent of clinical improvement in mild to moderate cases.
Glenmark Pharmaceuticals successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its in-house R&D team.
After that the firm filed the drug for clinical trial to which the DCGI gave approval and it became the first pharmaceutical company in India approved to conduct phase 3 clinical trial on mild to moderate Covid-19 patients.
Japan has been utilizing Favipiravir since 2014 for the treatment of novel or re-emerging influenza virus infections.
Glenmark announced last month about another clinical trial the firm is conducting to test the effectiveness of two antivirals Favipiravir and Umifenovir as a combination. The aim is to test the drug for treating moderate hospitalised adult Covid-19 patients in India.
The following updates have been made till now :
1. Favipiravir is a prescription based medicine. On day 1 , a dose of 1800mg is to be taken twice . Whereas, dose of 800mg is to be taken till the 14th day .
2. The drug shall be available in Hospitals as well as Retail Shops . It will be available as a 200mg tablet at an MRP of Rs 3500 , for a strip of 34 tablets .
3. Glenmark was the first company in India who had received the approval by the Drug Regulatory to conduct phase-3 clinical trial.
4. The company aims to provide the COVID-19 tablets to 82500 patients in the first month itself , considering two strips per person .
5. It can be used for heart patients or diabetic one’s suffering from mild to moderate Coronavirus symptoms.
Glenmark is producing the Active Pharmaceutical Ingredients (API) for Favipiravir , as its Ankleshwar Plant, while the formulation is being manufactured at its Baddi plant.
India on Saturday saw another record spike of 14,516 new Covid-19 cases in a single day, pushing the tally to 3,95,048, while the death toll rose to 12,948 with 375 new fatalities, according to Union Health Ministry data.