Antiviral Drug “Remdesivir” Promising a “ray of hope” in the fight against COVID-19?

Antiviral Drug “Remdesivir” Promising a “ray of hope” in the fight against COVID-19?

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity which has inhibitory effects on pathogenic animal and human corona viruses undergoing clinical trials in a number of countries as a potential treatment for COVID-19.Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein.

Ø  Remdesivir is a ‘viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying)

Ø  Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.

Ø  Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens that cause MERS and SARS, which are corona viruses structurally similar to SARS-CoV-2, the corona virus that causes COVID-19.

Remdesivir Clinical Trials

Gilead has initiated two Phase III clinical studies (Phase III clinical study usually involves thousands of participants who have the condition that new medication is meant treat. Phase III trials is for therapeutic conformity and will evaluate, how investigational new drug works in comparison to existing medications for the same condition ) to evaluate the safety and efficacy of Remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing. This randomized, open-label, multicenter studies began enrolling patients in early 2020.

The first of two studies evaluated the safety and efficacy of both a 5-day and a 10-day dosing duration of Remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study evaluated the safety and efficacy of the same dosing regimens of Remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone.

On April 29, 2020 The National institute of Allergy and infectious diseases (NIAID) said that a preliminary data analysis of the trial data from 1,063 patients found patients taking the drug recovered 31% faster than those taking the placebo. In Remdesivir patients, the median time to recovery was 11 days. In placebo patients, it was 15 days.

EMA starts rolling review of Remdesivir for COVID-19

In Europe, EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine Remdesivir for the treatment of corona virus disease (COVID-19).

A rolling review is one of the regulatory tools available to the Agency to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic.

Under normal circumstances, all data supporting a marketing authorisation application must be submitted at the start of the evaluation procedure. In the case of a rolling review, CHMP Rapporteurs are appointed whilst development is still ongoing and the Agency reviews data as they become available.

Several rolling review cycles can be carried out during the evaluation of one product as data continue to emerge, with each cycle lasting around two weeks depending on the amount of data to be assessed. Once the data package is complete, the developer submits a formal marketing authorisation application which is then processed under a shortened timetable.

While the overall review timeline for Remdesivir cannot be anticipated at this moment, it is expected that this procedure will allow EMA to complete its assessment significantly earlier compared with a regular evaluation procedure, while still ensuring a robust scientific opinion is reached.