Indian Government approved Glenmark to manufacture and market Favipiravir in India for mild to moderate COVID-19 cases. Drugs Controller General of India (DCGI), issued this order to Glenmark Pharmaceuticals for launching antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 patients. Price at ₹103 per tablet, the prescription-based drug will be available as a 200 mg tablet at an MRP of ₹3,500 for a strip of 34 tablets.
Favipiravir will be available as a 200 mg tablet at a maximum retail price of Rs 3,500 for a strip of 34 tablets, the drugmaker said. FabiFlu is the first oral favipiravir-approved medication in India for the treatment of Covid-19, it said in a statement. It is a prescription-based medication, with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14.
The tablets are being produced by the company at its Baddi facility in Himachal Pradesh. The drug will be available both through hospitals and the retail Medical store. This approval comes at a time when cases in India are spiraling like never before, putting tremendous pressure on our healthcare system. Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country.Glenmark Pharmaceuticals
Facts Abouts Glenmark’s Favipiravir
- The recommended dose of Favipiravir is 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14. It is a prescription-based medicine.
- The drug will be available both through hospitals and the retail medical store.
- Ingredients (API) for the Favipiravir at its Ankleshwar plant, while the formulation is being manufactured at its Baddi plant.
- This Drug can be used for COVID-19 affected patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms.
- It offers rapid reduction in viral load within four days and provides faster symptomatic and radiological improvement. Favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate COVID-19 cases.
- Favipiravir is backed by strong clinical evidence, showing encouraging results in patients with mild to moderate Covid-19. It offers broad-spectrum RNA virus coverage with clinical improvement noted in 20-90 plus age group.
- Glenmark was the first company in India to receive the drug regulator’s approval to conduct a phase-3 clinical trial of Favipiravir antiviral tablets for Covid-19 patients.
- Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical, Japan, a subsidiary of Fujifilm Corporation.
- Considering a minimum of two strips per patient, Glenmark will be able to provide FabiFlu for about 82,500 patients in the first month itself.
Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use.
The drug will be available as a prescription-based medication for INR 103/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14. Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adults COVID-19 patients in India.