- Gilead has decided to stop a large study evaluating its COVID-19 drug Veklury in people with coronavirus infections who are at high risk of developing complications that could lead to hospitalization.
- The company explained how recent changes in the way these patients are treated suggest that Veklury wouldn't be addressing any unmet need, at least in its current form. Veklury is given as a multi-day infusion, and must be administered in hospitals or healthcare settings that meet certain criteria.
- "The primary unmet need for non-hospitalized patients with COVID-19 is for effective and convenient therapies that can be easily administered at home," Gilead said in a Tuesday statement. The company noted how it is still trying to develop more treatment options for non-hospitalized patients with COVID-19, including inhaled forms of Veklury as well as new oral antivirals.
Veklury, also known as remdesivir, has been a boon to Gilead's bottom line. It earned the company almost $2 billion from October to December, accounting for about a quarter of Gilead's total product sales over the three-month period. For 2021, the company expects between $2 billion and $3 billion worth of sales from the drug.
Gilead estimates that more than half of all patients hospitalized with COVID-19 in the U.S. are treated with Veklury. The company has been building a case for using its drug in non-hospitalized patients, though Tuesday's announcement indicates it will likely take more time.
Gilead said the decision to stop its late-stage study was due, in part, to difficulties getting patients to enroll. That may have to do with the logistical challenges of treatment, which requires an intravenous infusion over multiple days and in specific settings.
But the company also noted how its decision was influenced by changing needs of non-hospitalized patients with COVID-19. For these patients, many of who have mild or moderate disease, convenience is important, so treatments that can be given more rapidly, or at home rather than a healthcare facility, could hold an advantage.
On that front, things are changing quickly. Antibody drugs from Eli Lilly, Regeneron and Vir Biotechnology have shown powerful effects in reducing the risk of hospitalization or death when given to people recently diagnosed with COVID-19. And just this week, Regeneron announced positive results from a late-stage study testing a single subcutaneous injection of its treatment. The study found Regeneron's drug cut the risk of symptomatic coronavirus infections by 81% for people who didn't have the virus but were living in the same household as someone who did.
Elsewhere, companies like Pfizer, Merck & Co. and Atea Pharmaceuticals are researching oral antiviral drugs that, in theory, could make treatment much easier for many patients.
Against this backdrop, Gilead has concluded a drug like Veklury has limited use in non-hospitalized patients, at least until it comes in a more convenient package.
Gilead isn't giving up, though. The company said it's still working on novel, oral antivirals, and expects to see later this year results from a "proof-of-concept" study assessing inhalable remdesivir.