Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
The FDA has again recommended actions to resolve problems at Novo Nordisk’s ex-Catalent fill-finish facility in Indiana, leading Scholar Rock to drop the troubled plant from a filing for approval.
In 2024, Novo acquired the Bloomington, Indiana, plant and two other facilities when it paid $11 billion upfront to buy three Catalent sites. The deal added capacity to meet the booming demand for the GLP-1 injectables Ozempic and Wegovy. Novo also inherited customers that Catalent, a contract development and manufacturing organization (CDMO), made products for.
Quality problems at the Indiana plant led the FDA to reject applications for approval of products made at the Indiana facility. Scholar Rock, one of the affected clients, hailed the plant’s “significant progress” in March. Months later, Scholar Rock dropped the Indiana plant from its filing for approval.
The company removed the facility from its application for approval of a spinal muscular atrophy therapy, apitegromab, after learning that the FDA classified its April inspection of the plant as Official Action Indicated (OAI). An OAI classification indicates that the FDA recommends regulatory or administrative actions in response to an unacceptable state of compliance.
Scholar Rock tried to insulate itself from the potential problems at the Novo site when it refiled for approval earlier this year by adding a second fill-finish facility to its submission. Now, the filing for approval will proceed solely with the second facility, the company said on Friday.
The second facility “has a consistent track record of successful FDA and EMA inspections,” BMO Capital Markets analysts said in a Monday note to investors. Scholar Rock’s “preemptive inclusion” of the second facility in the filing mitigates concerns over a potential delay to U.S. approval, the analysts added. The biotech continues to expect the FDA to reach a decision for its drug candidate by Sept. 30.
Novo’s problems could cause “a mild, but manageable delay” in the European approval of apitegromab, BMO said. Scholar Rock had planned to include the Indiana plant in a filing for approval in Europe but now intends to use the second facility instead. That facility’s consistent track record means there is “little risk for an additional CMC-related delay to European approval,” the analysts said.
Regeneron could also be affected by ongoing problems at the Indiana facility. Like Scholar Rock, the big biotech received complete response letters in recent years because FDA inspectors found fault with the manufacturing site. Regeneron is working with multiple CDMOs to try to win approval for a prefilled syringe version of the eye disease drug Eylea HD this year, potentially mitigating the risk posed by the latest OAI.
“With Regeneron interacting with multiple fill-finish facilities that could replace Catalent, we do not see material risk to these timelines, but note approval will likely be driven by other non-Catalent facilities,” BMO analysts said.
