Women worldwide who count on Ferring Pharmaceuticals' flagship fertility drug may be out of luck for the foreseeable future.
That’s because the Swiss company announced a pause on global shipments of the injectable med, known as Menopur, citing “changes made in the manufacturing process” for Menopur's ingredients “by a third-party supplier,” a Ferring spokesperson told Fierce Pharma.
The move was first reported by Business Insider, which quoted a memo Ferring’s chief science officer, Elizabeth Garner, M.D., reportedly sent to healthcare providers Wednesday that informed them of the supply halt.
“We are currently reviewing this situation and will provide updates as appropriate,” the company’s spokesperson said via email. Ferring has alerted the FDA and other global regulators to the issue and is working to mitigate any disruptions to supply, he added.
As of Thursday, the therapy, known generically as injectable menotropins, had not turned up on the FDA’s online drug shortage database.
While Ferring is temporarily pausing shipments of its product, information reviewed to date suggest “the safety and efficacy of the product remains unaltered,” the company’s spokesperson explained. “Ferring is not aware of any evidence indicating that the changes in the manufacturing process pose any risks to patients.”
The move covers all shipments of Menopur, which triggers the release of eggs from the ovaries of women who are not ovulating. A spokesperson from the company’s Singapore division told Business Insider they could not comment on the potential timing of the product's return to the market. Women undergoing in vitro fertilization need daily doses of Menopur for up to 20 days, according to the drug’s label (PDF).
For all of 2022, Menopur brought home sales of around 753 million euros, Ferring said in its annual report published (PDF) in April.
On the whole, Ferring posted total 2021 revenues of 2.16 billion euros, rising 14% over the previous year at constant exchange rates.
The company is primarily focused on reproductive medicine and maternal health, and, with Menopur at the fore, Ferring has managed to grow sales in that segment of its business by 27% over the last two years, the company said in a release last spring.