Gilead recalls 2 lots of COVID-19 drug Veklury after finding glass particulates in vials

vials of Gilead Sciences COVID-19 coronavirus drug remdesivir on white background
Gilead Sciences Friday said it hadn't received any safety reports linked to the recall of two lots of COVID-19 antiviral Veklury. (Getty Images)

Gilead Sciences' surprise blockbuster Veklury has braved its share of efficacy critiques. Now, the drug has run up against a manufacturing glitch. 

Gilead is recalling two lots of the COVID-19 antiviral Veklury, also known as remdesivir, after a customer complaint flagged the presence of glass particulates. Gilead confirmed the complaint through its own investigation, the company said Friday. 

Veklury was among the vanguard of COVID-19 treatments last year. It remains the first and only coronavirus med to snag a full FDA approval. Despite questions about its efficacy, the antiviral has enjoyed a resurgence in the second half of 2021 thanks to the spread of virus variants and elevated hospitalization rates.

As for the recall, injecting a drug with glass particulates could cause local irritation or swelling, Gilead said. If a glass particulate reaches the blood vessels, however, it can travel to various organs and block blood vessels in the heart, lungs and brain, which can lead to stroke or even death, according to the company.

As of Friday, Gilead said it hadn't received any side effect reports linked to the recall.

The two affected lots were shipped out nationwide in October and November. The batches were set to expire in January 2024. 

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Gilead didn't say where the lots were manufactured, or by whom. The company didn't immediately respond to Fierce Pharma's request for comment. 

As one of the earliest drugs for COVID-19, Veklury's data profile has been put under a microscope. It took a blow last October when the World Health Organization published results from its 11,200-person Solidarity trial, which found that Veklury "appeared to have little or no effect on hospitalized COVID-19" when measured by the need for ventilation, the length of hospital stay and overall mortality. 

In a follow-up study dubbed NOR-Solidarity, Veklury and hydroxychloroquine failed to significantly clear the virus from hospitalized patients or affect the degree of respiratory failure and inflammation over standard care after 10 days. 

Meanwhile, Europe's Discovery trial published results in September showing patients on Veklury fared no better than those on standard care alone. 

Still, as variants spread, Veklury's popularity has been revived in recent months. The drug brought in $1.9 billion in the third quarter, well above the Zacks consensus of $502 million for the period. In 2020, Veklury generated $2.8 billion.

RELATED: Gilead nixes Veklury COVID-19 trial as vaccines roll out, more convenient drugs emerge for outpatients

On the manufacturing front, particulate contamination has caused headaches for other companies this year, too. Fresenius Kabi in January pulled one lot of the anti-inflammatory drug ketorolac tromethamine injection after particulates surfaced in reserve samples. 

And generics juggernaut Teva Pharmaceutical in July yanked one lot of its cancer med topotecan injection after a pharmacy complaint flagged the presence of a single glass particulate in a vial of the drug. A follow-up review of the sample turned up two other particles, which were ID'd as grey silicone and "translucent, colorless cotton fiber."