Nearly 80% of all COVID-19 positive cases in India are under this category. FabiFlu is India’s first oral antiviral drug for treatment of mild & moderate COVID-19 patients, the company said.
“It is a significant step in the fight against COVID-19 India. Glenmark is leading the flight. We are not looking it as a business opportunity. The priority is to make the drug available to as many patients and save lives,” said Sujesh Vasudevan, president, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals Limited in a video conference.
The company had on Friday received approval from Indian drug regulator for manufacturing and marketing of Favipiravir in oral form in India.
On Saturday the company said the drug would be available from the evening near its factory areas and pan India in 7 to 10 days.
The drug will be available in strips containing 34 tables priced at ₹3,500 which works out to be ₹103 per tablet.
The prescribed dose is 18 tablets on the first day with 9 tablets of 200 mg each in morning and evening. From second day onwards the patient needs to take 4 tablets each in morning and day. The treatment can last upto 14 days. Patients in the age group of 18 and 75 can have it.
Since it is an oral medicine, the patient can stay at home. The drug is currently under clinical trial on 150 patients at 11 sites in India.
“Studies conducted on Favipiravir in Russia, Japan and China point to rapid reduction in viral load, faster fever reduction, faster reduction of chest CT changes and faster clinical recovery,” said Dr Monika Tandon, VP, Head, Clinical Development, Glenmark.
Since COVID-19 cases are rising every day and the healthcare infrastructure has come under severe strain, the availability of the drug will help in tracking the spread, she said.
“The need of the hour is to help healthcare professionals by enabling patients to get treatment at home and help in faster recovery of patients, save lives,” said Dr. Tandon.
Glenmark said it identified Favipiravir as a potential candidate because it has a proven in-virto activity against SARS CoV2 and has wide therapeutic safety margins for COVID-19 dose.
“Since it is an oral product, it is a big benefit when hospital infrastructure is under strain,” she said.
Glenmark is ramping up production to cater to the growing demand of the drug as India on June 20, 2020 added 14,516 new cases to the total number of 39,5048 confirmed cases. Though the fatality rate in India is low at 3.28% as compared to global average of 5.37%, the constant rise in cases is still a matter of worry.
Oral Favipiravir has been approved under the accelerated approval process taking into account the severity of the disease.
The drug has been cleared under emergency use authorisation which is a provision that allows countries to use drugs that are urgently needed for an emergency situation or health crisis like this pandemic.
“It is for restricted use. Its use entails responsible medication where every patient must have signed informed consent before start of treatment,” Dr. Tandon said adding that approval was given based on global evidence and the ongoing clinical trial on 150 subjects.
The drug will be available both at hospitals and chemists but will be sold strictly only on prescription.
The company is now planning a combination of antiviral drugs Favipiravir and Umifenovir which is applied for influenza for treatment of COVID-19 for which clinical trials will commence soon.