The maker of the first antiviral drug to get authorization from regulators for Covid-19 anticipates meeting real-time demand for it around the world this month and is already meeting demand in the U.S.
Foster City, California-based Gilead Sciences said Thursday that it was meeting demand thanks to early investments in manufacturing Veklury (remdesivir) and would be able to provide sufficient supplies of the drug globally, even if there are potential surges of the coronavirus disease.
Starting Thursday, the company said it would be responsible for distributing the drug in the U.S., its distribution agreement with the U.S. government having concluded, with AmerisourceBergen – one of the three largest pharmaceutical distribution companies in the country – continuing to serve as sole U.S. distributor.
Gilead also said it had donated 1.5 million vials of Veklury for use in clinical trials around the world. ClinicalTrials.gov lists more than 50 studies testing the drug in Covid-19, including in combination with other agents.
Veklury received an emergency use authorization from the Food and Drug Administration in May, on the back of results of a Phase III clinical trial sponsored by the National Institute of Allergy and Infectious Diseases that compared Veklury – at the time known only by its chemical name, remdesivir – against placebo. Data from the study showed a statistically significant improvement in the amount of time to recovery for hospitalized patients with Covid-19 who received the drug, compared with those in the placebo arm.
Still, the development and distribution of the drug has not been without criticism. In July, the Department of Health and Human Services said it had acquired all supplies of Veklury for that month and 90% of supplies for the subsequent two months, leading to criticism that it had left other countries without. Meanwhile, experts have said the clinical trials of the drug were insufficiently diverse in their recruitment, with percentages of Black, Latino and Native American patients that were low in comparison to how those communities have been affected by the disease.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Since then, a number of other potential treatments have been tested as well, including drugs to relieve the systemic inflammatory symptoms that are associated with severe Covid-19, and also antiviral drugs, including those specifically designed for the disease. Veklury was originally developed for Ebola virus and then tested in preclinical models for other coronaviruses, including SARS-CoV-1 – the virus that caused the 2002-2004 SARS epidemic – and MERS-CoV.
Antiviral drugs in development include Regeneron Pharmaceuticals’ REGN-COV2, a cocktail of two monoclonal antibodies designed to target two regions of the SARS-CoV-2 virus’ spike protein and thus thwart resistance mechanisms, and multiple drugs developed by Vir Biotechnology, including the monoclonal antibody VIR-7831 and the inhaled RNA-interference drug VIR-2703. The company is respectively developing the drugs with GlaxoSmithKline and Alnylam Pharmaceuticals.
Photo: MysteryShot, Getty Images
