GSK yanks 2 batches of its asthma blockbuster Nucala in Taiwan over glass particle fears

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来源: FiercePharma

GSK initiated the recall, in consultation with Taiwan Food and Drug Administration, as a "precautionary measure," a spokesperson said.

In the world of drug packaging, a vial is a vial, the product the product, and never the twain shall meet. When those standards start to slip, recalls are sure to follow.

Now, GSK has become the latest drugmaker to learn that lesson.

This week, Taiwan’s Food and Drug Administration initiated a recall of two batches of GSK’s severe asthma injection Nucala after glass particles were found in a vial of the drug.

The regulator said the recall is expected to wrap up by August 7, local outlet Focus Taiwan reported Tuesday.

GSK confirmed the recall to Fierce Pharma. In an emailed statement, a GSK spokesperson said that none of the product reported in the complaint was administered to patients.

“GSK—in consultation with Taiwan Food and Drug Administration (TFDA)—has taken the decision to voluntarily recall two batches (#MX9M and #S34T) of NUCALA FD 100MG in Taiwan as a precautionary measure,” the company added.

GSK learned of the issue after receiving a complaint from a hospital in Taiwan about the presence of glass particles in one reconstituted vial of the drug.

The suspect vial flagged in the alert came from a batch with the lot number MX9M. Concerns about other bottles of Nucala made on the same production line have prompted a recall of a second lot, dubbed S34T.

Both batches were produced from a “related semi-finished batch,” according to the company, which noted that no other markets are affected by the recall.

All told, the pull covers 2,591 bottles of the respiratory medication, around 1,500 of which have already been sold in Taiwan, the deputy director of the country’s FDA told Focus Taiwan. On average, the country uses about 4,690 bottles of Nucala per year, with no readily available alternative, he added. In turn, GSK Taiwan has reportedly said it’s working to allocate a new shipment of 1,512 bottles from abroad.

Nucala is a blockbuster member of GSK’s immuno-inflammation and respiratory business, where the drug brought home sales of £1,423 million (about $1.86 billion) for all of 2022. Often in competition with AstraZeneca’s rival asthma star Fasenra, Nucala first crossed the 1-billion-pound threshold in 2021. The med has picked up a clutch of additional indications since its original approval in 2015 for severe asthma, including nods for granulomatosis with polyangiitis, hypereosinophilic syndrome and rhinosinusitis with nasal polyps.

Meanwhile, glass-fueled recalls aren’t exactly unique to GSK. In October, Exela Pharma Sciences yanked 49 lots of an injectable used to treat kidney disease complications over safety concerns of “vial breakage and flying glass.”

In addition, Gilead last March suffered an FDA rejection on its application for the long-acting HIV med lenacapavir over concerns that incompatibility between the drug and the vials could creative “subvisible” glass particles.

Gilead ultimately refiled its U.S. application with an alternative vial type and snared approval for lenacapavir—now known as Sunlenca—in December.

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