DCGI approves Themis Medicare’s Viralex as COVID-19 treatment
The drug is also effective for viruses causing viral respiratory infections
The Drugs Controller General of India (DCGI) has approved Viralex — Inosine Pranobex as the new option for COVID-19 treatment that is effective irrespective of the new variants. The drug is effective not just in COVID-19, but also in other viral respiratory infections, a statement from Themis Medicare said.
The safety and efficacy of the drug has been demonstrated through double-blind, randomised placebo control multi-centre trial in India with the drug showing significantly early clinical response and cure. The trials were conducted during the Delta wave of COVID-19 and showed early improvement and complete relief from symptoms in patients who received Viralex, notified the statement.
It also said that Viralex – Inosine Pranobex has been approved for treatment of influenza and other Acute Viral Respiratory Infections (AVRI), including COVID -19, mucocutaneous herpes, genital wart and Subacute Sclerosing Panencephalitis (SSPE) by DCGI.
Inosine Pranobex is an immuno-modulatory agent with an anti-viral action having established safety profile. It has been used effectively for the treatment of viral infections in several countries worldwide and the repurposing of the drug for COVID-19 follows the results of stringent double-blind randomised controlled clinical trials conducted by Themis Medicare in India, the statement added.
Natural Killer (NK) cells are the first-line defence in fighting any viral infection; they kill the virus-infected cells (cell-mediated cytotoxicity) and prevent spread of the virus in the body. Recent researches conducted at the Birmingham University and Oxford University report that Inosine Pranobex strengthens NK cell mediated cytotoxicity by two ways: (1) increasing NK cell numbers and (2) inducing metabolic activation and NKG2D ligand expression on virus-infected cell, thus facilitating identification of these infected cells by NK cells, it mentioned.
Viralex action in the treatment of mild-to-moderate COVID-19 and other viral/respiratory infections is through its immuno-modulatory and antiviral properties that bolster the body’s defences against viral infections by enhancing both innate and adaptive immunity. The boost to the immune system enhances immunity to offer early improvement and cure from symptoms. Due to its dual mode of action, this medicine is also useful in patients with co-morbidities and suppressed immunity, the statement stated.