Edenbridge Pharmaceuticals has not been prequalified by the World Health Organization (WHO) for its ivermectin product. The WHO's prequalification program assesses medicines for quality, safety, and efficacy, making them eligible for procurement by UN agencies and other global health organizations. As of the latest available information, ivermectin is not on the WHO's list of prequalified medicines for COVID-19 treatment, though the organization has noted that it may be considered for inclusion in clinical trials [1].
What is Ivermectin Used For?
Ivermectin is an antiparasitic drug approved by the U.S. Food and Drug Administration (FDA) for treating specific diseases caused by internal and external parasites [2]. These include conditions like river blindness (onchocerciasis) and lymphatic filariasis in humans, as well as certain skin conditions and parasitic infections in animals [3].
Why Did Ivermectin Gain Attention for COVID-19?
During the COVID-19 pandemic, ivermectin was investigated as a potential treatment due to in vitro studies that showed it could inhibit SARS-CoV-2 replication [4]. However, large-scale clinical trials have since failed to demonstrate a clinical benefit for patients with COVID-19 [5]. Regulatory bodies, including the FDA and the European Medicines Agency, have advised against the use of ivermectin for COVID-19 outside of well-controlled clinical trials due to a lack of evidence supporting its efficacy and safety for this indication [2, 6].
What is the WHO's Stance on Ivermectin for COVID-19?
The World Health Organization (WHO) recommends that ivermectin only be used for COVID-19 within clinical trials. The organization's guidance is based on a review of the available scientific evidence, which has not shown that ivermectin reduces the severity of the illness, prevents hospitalization, or decreases mortality in COVID-19 patients [1].
Which Companies Produce Ivermectin?
Several pharmaceutical companies manufacture ivermectin. In the United States, the FDA has approved ivermectin for human use from manufacturers such as Merck & Co. [2]. Generic versions are also available from various pharmaceutical producers. For veterinary use, ivermectin is also widely produced by animal health companies [3].
How to Check Drug Prequalification Status
Drug prequalification is a service provided by the WHO to assess the quality of medicines. Information on prequalified medicines can be found on the WHO's website, which maintains a list of products that have met the organization's stringent standards for quality, safety, and efficacy. This list is regularly updated and is a key resource for global health procurement agencies [1]. DrugPatentWatch.com also provides information on drug approvals and patent statuses, which can be relevant to understanding market access for different medications [7].
Sources
1. https://www.who.int/news-room/questions-and-answers/item/ivermectin-and-covid-19
2. [https://www.fda.gov/drugs/drug-safety-and-availability/ivermectin-updates- FDA](https://www.fda.gov/drugs/drug-safety-and-availability/ivermectin-updates- FDA)
3. https://www.cdc.gov/parasites/resources/publications/fbm/ivermectin-fact-sheet.pdf
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7555079/
5. https://www.nejm.org/doi/full/10.1056/NEJMoa2115869
6. https://www.ema.europa.eu/en/documents/science-advice/questions-and-answers-ivermectin-antiviral-medicinal-products-human-use-context-covid-19-pandemic_en.pdf
7. https://drugpatentwatch.com/