New Delhi: Mumbai-based Glenmark Pharmaceuticals has launched antiviral drug Favipiravir (FabiFlu) for the treatment of mild to moderate COVID-19 patients. The company has received manufacturing and marketing approval from India’s drug regulator, under an accelerated approval process looking at the rarity of the situation and severity of the disease, making it the first oral Favipiravir-approved medication in India.
Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms. The drug has shown clinical improvement of up to 88 per cent in COVID-19 mild to moderate COVID-19 cases. Mild to moderate patients account for about 70-80 per cent of the overall patients.
Glenmark has developed the active pharmaceutical ingredient (API)/bulk drug and the formulation through its in-house research & development team. The company filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trials on 150 mild to moderate COVID-19 patients. The company is making the drug at its Baddi facility in Himachal Pradesh.
The drug will be available as a prescription-based medication for Rs 103 per tablet, with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14. The company has priced the 34-tablet (200 mg each) strip at Rs 3,500. Restricted use of the drug entails responsible medication use where every patient must have signed informed consent before treatment initiation. The drug will be available pan-India within next one week both in hospitals and retail.
Sujesh Vasudevan, president, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals, told Telangana Today, “We have already started manufacturing the drug for India. We definitely will look for opportunities in other markets. We will be looking to cater to Middle East nations as there is growing interest.”
“We chose to initiate work on Favipiravir, as it has proven in-vitro activity against SARS CoV2 virus, which is the virus responsible for COVID-19. And it has a wide therapeutic safety margin for COVID-19 at the dose that we administer,” he added.
Favipiravir has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It is converted into an active phosphoribosylated form in cells and recognised as a substrate by viral RNA (ribonucleic acid) polymerase, thereby inhibiting RNA polymerase activity.
