Sources told Moneycontrol that Glenmark's Favipiravir is expected to get approval from drug regulator any moment, based on the intermediate data from the clinical trials given the urgency of the situation
Optimus Pharma, the Hyderabad-based drugmaker said it has started shipping antiviral tablet Favipiravir to the UAE, where the drug is approved for treating COVID-19 patients.
Optimus said it has developed the drug internally and has the capacity to produce 3 billion tablets per annum from manufacturing plant compliant with USFDA, EU and WHO regulatory standards. The company said it's also receiving multiple enquiries from potential customers regarding the supply of the drug.
Along with UAE, Favipiravir is approved in Japan, China and Russia, for COVID-19 and has a dosage duration of 4-14 days based on the condition of the patient. The drug is yet to be approved in India for treating COVID-19.
The intermediate data relating to a clinical trial in Russian involving 330 patients have found Favipiravir eliminating the virus in four days compared to nine days with standard therapy. The full data of the trial is yet out to be out. But Russia has approved the drug for treating COVID-19. Russia has reported 569,000 COVID-19 cases, the third-highest in the world.
The antiviral is particularly useful in the mild to moderate cases, which accounts for a majority of COVID-19 infections.
Prashanth Reddy, Director of Optimus told Moneycontrol that the company had applied for approval with Central Drugs Standard Control Organisation (CDSCO) for the finished dosage and is under process for receiving fast-track approval from the drug authorities.
To be sure, it isn't Optimus alone, several other companies including Delhi-based Brinton Pharmaceuticals, Bengaluru-based Strides Pharma and Mumbai-based Lasa Supergenerics have all have already applied or in the process of seeking approval from CDSCO.
Brinton Pharmaceuticals said it will market Favipiravir under the brand name Faviton that will be available in 200mg and 400mg tablets for export.
Brinton is planning to launch it in 18 countries where it has a presence.
Dr Omkar Herlekar, Chairman– Lasa Supergenerics said efforts over the company is looking to manufacture close to 10,000 doses, to begin with, and in the meanwhile, also apply for the drug license with competent authorities and continue to seek strategic private investments or government aid.
All eyes on Glenmark's FavipiravirBut all approvals of Favipiravir are linked to data on Glenmark's clinical trial.
Glenmark is conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients, enrolled from 10 leading government and private hospitals across India.
Glenmark is the first company in India to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India. The company estimates trial to complete by July-August.
Sources told Moneycontrol that Glenmark's Favipiravir is expected to get an emergency use authorisation (EUA) any moment, based on the intermediate data from the clinical trials given the urgency of the situation.
Glenmark spokesperson declined to comment.
Favipiravir, sold under the brand name Avigan of Fujifilm Toyama Chemical, is typically used to treat influenza and works by interfering and blocking the virus replication process in our cells.
The drug isn't protected by patents in India, paving the way for the launch of cheaper generic versions. Favipiravir comes as a pill, so it's convenient for the patient.The safety data is already well established, as the drug is a repurposed one.