Dive Brief:
- After warning investors earlier this month of a possible delay, Regeneron Pharmaceuticals on Tuesday confirmed that U.S. regulators will not approve its experimental multiple myeloma drug at this time.
- The Food and Drug Administration previously identified flaws at a third-party fill/finish manufacturing facility. And while the manufacturer believes the issues have been resolved, a new inspection must take place before Regeneron can win approval of its medicine. The inspection is likely to happen in “coming months,” the company said.
- Regeneron emphasized the manufacturing issue was the only one related to approvability of its drug, called linvoseltamab. Executives told investors during an Aug. 1 conference call that they have not been informed by the FDA of any safety or efficacy concerns.
Dive Insight:
While not unexpected, the FDA’s complete response letter represents a delay for Regeneron, which is vying to enter an already competitive market for a type of cancer treatment known as a bispecific antibody.
Johnson & Johnson won FDA approval to sell its option, Tecvayli, for multiple myeloma in October 2022. And Pfizer in August 2023 got clearance to enter the market with a treatment called Elrexfio. The drugs work by targeting both diseased cells and the T cells that spur an immune response.
Regeneron is hoping to distinguish linvoseltamab from already approved medicines by showcasing an administration schedule that requires less time in the hospital. And while it’s difficult to compare clinical trials run by different companies, Regeneron may have a slightly stronger data set to show doctors, according to a company presentation.
But first the medicine has to reach the market. Regeneron executives earlier this month noted how they aren’t alone in dealing with third-party manufacturing issues. Indeed, Eli Lilly, AbbVie and partners Merck & Co. and Daiichi Sankyo have encountered similar problems in the last year.
Regeneron said it’s working closely with the third-party manufacturer and the FDA to win approval of the drug, designed to treat patients with relapsed or refractory multiple myeloma that has progressed after patients tried at least three other therapies. A European regulatory review is ongoing.
Earlier this year, Regeneron received a complete response letter for a different bispecific antibody called odronextamab, due to the enrollment status of a confirmatory trial.
