(Reuters) -Scynexis said on Monday it would voluntarily recall its antifungal pill, which it has licensed to GSK, due to risk of cross-contamination with a potential allergy-inducing compound, sending the drugmaker’s shares tumbling 32% premarket.
The drugmaker said it became aware substances used to make drugs that contain beta-lactam are manufactured using equipment also used to make its treatment, called Brexafemme.
The U.S. Food and Drug Administration’s guidelines require companies segregate the manufacturing of beta-lactam compounds from other drugs because they may trigger hypersensitivity or an allergic reaction in some people.
Scynexis said the recall was cautionary and that it had not received any report of any adverse events due to possible beta-lactam cross contamination.
It had also placed a temporary hold on clinical studies of the drug until a mitigation strategy and a resupply plan were determined.
The yeast infection pill, which was first approved in 2021, brought in sales of $5 million in 2022. GSK, which licensed the pill from Scynexis in March, had said it was confident it can change the sales trajectory of the drug over time due to its experience building awareness among doctors and patients.
Up to 75% of women have at least one episode of vulvovaginal candidiasis, commonly known as a vaginal yeast infection, in their lifetimes, according to the U.S. Centers for Disease Control and Prevention.
There has been little breakthrough in the market for next-generation antibiotics and antifungals, fuelling concerns about the rise of drug-resistant bacteria and other microbes due to the misuse and overuse of antibiotics.
(Reporting by Manas Mishra in Bengaluru; Editing by Krishna Chandra Eluri)
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