Welcome to Praava Community
- By Dr. Zaheed Husain, Ph.D.,
- 16 May, 2020
What is Remdesivir?
Remdesivir is an investigational drug that has not been approved by any regulatory authority, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet known. It has broad antiviral action against several viruses including the coronaviruses that was earlier developed against the Ebola virus in 2014 but did not do well in large clinical trials.
Is Remdesivir Food and Drug Administration (FDA) approved?
The Food and Drug Administration (FDA) approved an ‘emergency use authorization’ (EUA) for Remdesivir only. This means it can be prescribed for hospitalized patients infected with the coronavirus.
Is Remdesivir effective in treating COVID-19?
Remdesivir has shown to be relatively effective in treating COVID-19 patients to the extent it shortens the duration of the symptoms. According to a National Institutes of Health announcement, in a randomized clinical trial “remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery.” Patients receiving remdesivir had a 31% faster time to recovery than those receiving placebo. The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. The time to recovery was defined as the time when patients were well enough to leave the hospital or could return to normal activity levels.
Is Remdesivir the answer to the coronavirus or can it cure coronavirus?
In short - no. The same day the FDA announcement came out, a study by Chinese researchers published in The Lancet found remdesivir did not perform better than a placebo in seriously ill COVID-19 patients. This dampened the excitement about remdesivir and expectations that it could be the “silver bullet” against COVID-19. Scientists and clinicians have questioned the validity of changing the approval criteria midway through the trial and have also questioned the lack of statistical significance in survival advantages between treated and placebo groups. Former Harvard Professor and HIV treatment pioneer Bill Haseltine has expressed concerns about the premature approval without release of all the data, pointing out that remdesivir has significant adverse effects and wondered if the decision had economic, political, or geopolitical reasons.
Which company originally manufactured Remdesivir?
US-based biopharmaceutical company Gilead Sciences, Inc. manufactures Remdesivir. The company has accelerated production of the drug since January and has 1.5 million doses, to date.
Is Remdesivir available in Bangladesh?
Eskayef Pharmaceuticals, one of the leading drug manufacturing companies of the country, has successfully produced Remdesivir. In early May 2020, the Directorate General of Drug Administration permitted six companies to produce the drug and they are Beximco, Incepta, Eskayef (SK-F) Square, Beacon, and Healthcare. These companies currently have approval to manufacture but have not started distribution of the drug yet.
How is the drug taken?
Remdesivir is administered intravenously to patients, meaning it needs to be injected.
Can it be bought at a pharmacy?
The pharmaceutical companies in Bangladesh can initially supply the drug to the hospitals that have been permitted to treat COVID-19. It will not be available in pharmacies since it needs to be administered intravenously.
How much will it cost?
A single dose of remdesivir will be priced at Tk 5,500, according to officials of the Directorate General of Drug Administration and the pharmaceutical companies.
When can remdesivir be available for use in Bangladesh?
The DG of the Directorate General of Drug Administration Major General Mahbubur Rahman, informed the press that Bangladesh is likely to begin using remdesivir by May 20.