Chinese drug regulators suspended the import, sale and use of UCB's anti-seizure drug levetiracetam following an inspection of the company's manufacturing facility in Belgium.
In a brief statement issued by China's National Medical Products Administration (NMPA), the agency said its inspectors found “the validity period of some batches of products” were “inconsistent with the validity period of registration approval” and did not meet China’s good manufacturing practices, according to a translation.
UCB markets levetiracetam as Keppra. In the first half of 2022, the company reported 380 million euros in sales for the drug, a 22% decline from the same period in 2021.
China's NMPA didn't disclose the date of the inspection.
The Keppra setback follows another recent manufacturing-related hiccup for UCB's psoriasis prospect bimekizumab at the FDA. In May, the agency said it couldn't approve the application until “certain pre-approval inspection observations" are resolved. At the time, UCB said it was working to address the manufacturing issues as quickly as possible. That rejection followed a prior FDA delay for the candidate.
Bimekizumab is a closely watched drug prospect carrying blockbuster sales expectations. The drug previously beat Johnson & Johnson's popular Stelara in a phase 3 trial and is already approved in some key markets.
After the FDA rejection, UCB lowered its annual earnings projections in June. The company also cited inflation and the war in Ukraine as contributing to its financial troubles for the year.