Home / India News / Glenmark’s Covid-19 drug to nod to Hetero and Cipla for remdesivir: Latest on fight against coronavirus
Glenmark Pharmaceuticals has said it has launched antiviral drug favipiravir, under the brand name FabiFlu, for the treatment of cases of mild to moderate Covid-19.
FabiFlu, the first oral favipiravir approved medication in India for the treatment of the coronavirus disease, will be available as a 200mg tablet at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets, Glenmark has said.
The Drug Controller General of India (DCGI) granted Glenmark Pharmaceuticals the permission to manufacture and market favipiravir for “restricted emergency use” in mild to moderate cases.
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Favipiravir, which has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections, has shown clinical improvement of up to 88% in mild to moderate Covid-19 cases, the company has said.
Glenmark had announced in May that it is conducting another clinical trial to evaluate the efficacy of two antivirals favipiravir and umifenovir as a combination therapy in moderate hospitalised adult Covid-19 patients in India.
Hetero and Cipla have been given a nod by India’s drug regulator to manufacture and market antiviral drug remdesivir for “restricted emergency use” on hospitalised Covid-19 patients.
“The approval to Hetero and Cipla was given on Saturday,” news agency PTI quoted a source as saying.
Written informed consent of each patient is required before the use of remdesivir and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted.
The Union health ministry, in its ‘Clinical Management Protocols for COVID-19’, recommended the use of remdesivir on patients in the moderate stage of the disease that is, those on oxygen.
The drug has been included as an “investigational therapy” only for restricted emergency use purposes.
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Cipla and Hetero Labs have already entered into non-exclusive licensing agreements with US pharma giant Gilead Sciences, which is the patent holder of remdesivir.
Gilead Sciences had applied to the Indian Drug Regulatory Agency, Central Drug Control Standard Organisation (CDCSO), for import and marketing of remdesivir on May 29. After due deliberations, permission under emergency use authorisation was granted by DCGI on June 1 in the interest of patient safety and obtaining further data.
Gilead had signed non-exclusive voluntary licensing agreements with five generic pharma firms -- Cipla, Jubilant Life Sciences, Hetero, BRD and Mylan to manufacture and distribute remdesivir, a potential antiviral therapy for Covid-19.
Following which, Cipla, Hetero Labs, BRD, Mylan, Jubilant Life Sciences, Dr Reddy’s Labs approached India’s drug regulator to make and sell remdesivir in the country and are still awaiting permission.
These applications are being processed by the CDSCO in accordance with the laid down procedures.
The health ministry had earlier said that these companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc.
It has said that being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very critical for patient safety and this data needs to be provided by the companies.
Serum Institute, the world’s largest manufacturer of vaccines by volume, is working on several candidates for coronavirus—including potentially mass-producing the AstraZeneca and Oxford university one—as well as developing its own.
(With agency inputs)