Already boasting a positive recommendation overseas, Novo’s hemophilia A newcomer Frehemgo will have to wait a while longer before taking a crack at the U.S. market.
Shortly before the weekend, Novo—which had been expecting an approval decision on its bispecific antibody by the third quarter—said the FDA had announced its review was “still ongoing,” without communicating an updated timeline for the regulatory action.
The delay comes down to issues the FDA uncovered during a pre-license inspection of Novo’s Frehemgo (denecimig) manufacturing site, which occurred after Novo filed its application for approval last September, the company said in a release.
Specifically, as the calendar has now turned to October and 2026’s fourth quarter begins, the FDA has informed Novo that “ongoing facility remediation activities are the cause of the extension” of its review.
Novo is specifically seeking approval in adults and kids without hemophilia A, with Frehemgo winning its first green light in Saudi Arabia and a positive recommendation in the European Union last month.
With the delay, the FDA hasn’t singled out any efficacy or safety data deficiencies, Novo said. The company stressed that it’s continuing to work through remediation work at the unnamed facility as it works closely with the agency on the matter.
The company was also clear that the issue is expected to have a limited impact for now.
The observations at the Frehemgo site aren’t impacting other Novo products already on the market, the company clarified. Additionally, the extra time taken by the FDA won’t affect Novo’s 2026 outlook, and pending an approval, the drugmaker still plans to launch its hemophilia medicine in the U.S. in the first half of next year.
“Haemophilia A patients should expect more from their standard of care,” said Mike Doustdar, Novo CEO, in a statement.
“As Novo prepares to bring denecimig to market, our ambition is to help make better care something they can count on,” he continued. “Novo is already in the process of addressing the FDA's requests as efficiently as possible and continuing to work closely with the Agency toward bringing denecimig to patients in the US.”
Novo did not specify which of its manufacturing sites is responsible for the delay.
For some time now, the company has been working through regulatory headaches at the Bloomington, Indiana facility it acquired from Catalent under a transaction following Novo Holdings’ buyout of the CDMO in late 2024.
Elsewhere, regulators have already started endorsing Novo’s factor VIII-a mimetic in Saudi Arabia, as well as Europe, where the EMA’s Committee for Medicinal Products for Human Use (CHMP) last month gave a marketing recommendation to Frehemgo to prevent or reduce bleeding episodes in adults and kids with hemophilia A.
Novo’s next-generation offering will come up directly against Roche’s blockbuster and hemophilia market champion Hemlibra, which generated sales of roughly $5.8 billion in 2025.
In Europe specifically, Novo has said it’s planning for an initial hemophilia launch before the end of 2026, which a broader rollout across the bloc slated for 2027.
Frehemgo could carve out a niche as a differentiating product for Novo, which has been heavily focused on its diabetes and obesity franchises of late, namely through its popular semaglutide-based franchise of GLP-1s.