The Drug Controller General of India (DCGI) has approved to manufacture and market of the antiviral drug ‘Viralex®️’ for the treatment of mild and moderate Covid-19 in India. This new drug will be manufactured by Themis Medicare Limited, a pharmaceutical company from Mumbai. According to the firm, the DCGI approval was granted after the Viralex®️ was found effective and well-tolerated in mild to moderate Covid-19 in the two Randomised Controlled Clinical Trials (RCT) conducted on 499 Indian patients. Themis has been granted permission to manufacture and market this new drug for restricted emergency use as an add-on therapy for the treatment of mild and moderate Covid-1. Themis Medicare claims that as per the RCT results, the drug helps in the early relief of the clinical symptoms in mild to moderate Covid-19 patients. VIRALEX®️ is an immunomodulatory agent with antiviral activity across a broad spectrum. It boosts the body’s defenses against viral infections by enhancing both innate and adaptive immunity. It demonstrated dose-dependent suppression of viral replication against SARS-CoV-2 in an in-vitro investigation initiated by Themis.
According to the company, the generic name of Viralex®️ is Inosinepranobex and the approval from DCGI was based on the robust Phase-1 and Phase-2 RCTs conducted in India and the well-established safety profile of the drug. In the Phase-3 randomized, double-blind, placebo-controlled studies, over 80.17 percent of patients treated with VIRALEX®️ demonstrated clinical improvement on day six, compared to 52.38 percent in the controlled group. On day 6 of treatment, the clinical cure was also considerably higher in the VIRALEX®️ group than in the placebo group. Patients who received VIRALEX®️ saw rapid improvement and complete remission of symptoms. Patients handled this medication well and experienced no major adverse effects.
The investigation was conducted during the pandemic Delta wave. The Randomized, Double-Blind, Placebo-controlled, Multicentre Trial is regarded as the gold standard in clinical research for assessing treatments against diseases. Themis is one of the few firms that has submitted evidence from a larger number of patients in RCTs for approval in COVID-19 management. VIRALEX®️ will be manufactured at an EU-GMP certified facility with the highest safety standards and it will be available on the prescription in the form of a 500 mg tablet at an affordable price. The drug is an immunomodulatory agent with antiviral activity across a broad spectrum. It boosts the body’s defenses against viral infections by enhancing both innate and adaptive immunity.
It demonstrated dose-dependent suppression of viral replication against SARS-CoV-2 in an in-vitro investigation initiated by Themis. Dr. Sachin Patel, Managing Director & CEO, Themis Medicare Limited said, “Our goal has always been to provide drugs that help patients and improve healthcare. Given the current state of COVID-19 in India, this is our endeavor to contribute to the people’s well-being. “Due to the virus’s tendency to mutate, the pandemic remains uncertain. We expect that early access to effective treatments like VIRALEX®️ will lessen the burden on the health care system”, To meet the unmet need in the management of the pandemic, Dr. Ashok Swain, HeadClinical Development, commended the entire Themis Medicare Ltd. team for attaining this critical milestone. “VIRALEX®️is a new ray of hope in these challenging times,” he said. According to renowned pulmonologist Dr. Raja Dhar, InosinePranobex is a medication that increases host immunity (immunomodulatory action) and can impact viral RNA, therefore inhibiting viral development. COVID 19 lacks phase 3 double-blind RCTs. In mild to moderate COVID19 patients, Themis Medicare has developed a trial that showed an early clinical response and reduced recovery time. This medicine, if utilised clinically, would minimise the load on the healthcare system, the firm claims.