US-based drugmaker Gilead Life Sciences is now attempting to develop a nebuliser version of its antiviral drug Remdesivir, the only authorised treatment in most countries for hospitalised COVID-19 patients. This version of Remdesivir will be used to treat mild to moderate COVID-19 patients in early stages of infection. Gilead this week got the US Food and Drug Administration (US FDA) clearance to start Phase 1 trial of the inhaled version of Remdesivir.
Gilead's move comes at a time when another antiviral drug, Favipiravir got marketing approval in many countries like India, Bangladesh, Russia and UAE, while many countries are conducting trials for clearance. This drug is indicated for use in early to moderate COVID-19 patients. Remdesivir, allowed for emergency use in COVID-19 patients from May 1, is currently given as an injection and can be used only in hospitals.
Favipiravir, earlier used as a drug to treat influenza, is already available in tablet form, which makes its use possible even outside hospital settings. Remdesivir was being developed as a treatment for Ebola, but recent trials found it effective against COVID-19. Meanwhile, Dexamethasone, an anti-inflammatory drug useful in COVID-19 treatment by reducing the risk of death by a third for patients on ventilators, is yet to be tested in mild to moderately infected patients.
As part of global sales, Gilead had entered into non-exclusive voluntary licensing agreements with nine generic drug makers, including six Indian drug makers - Cipla, Jubilant Life Sciences, Hetero Drugs, Dr Reddy's Laboratories, Biocon arm Syngene International and Zydus Cadila - to manufacture Remdesivir for distribution in 127 countries.
Last week, drug major Glenmark Pharmaceuticals commercially launched its indigenously developed Favipiravir with brand name FabiFlu in India. It is priced at Rs 3,500 for 34 tablets, which is likely to be much lower than the price of Indian versions of Remdesivir dosages. Now Glenmark is planning a large clinical trial with 1,000 patients to prove its efficacy and safety to take the drug to overseas markets and a big launch in India.
Already many healthcare experts across the globe have questioned the success rate of antivirals in COVID-19 treatment and claims related to cure. A Gilead small trial with Remdesivir in moderate patients itself showed a betterment rate of only 65 per cent in clinical symptoms, compared to patients with standard treatments.