It appears problems at Novo Nordisk’s recently acquired manufacturing facility in Indiana aren’t going to be solved any time soon. The FDA has tagged the former Catalent facility with an official action indicated (OAI) label, which is the most severe of the three inspection classifications issued by the agency.
The OAI designation—which identifies facilities that are at “an unacceptable state of compliance,” according to the regulator—is bad news for drugmakers who depend on the massive plant in Bloomington for contract manufacturing.
One of those companies is Scholar Rock, which is bidding for FDA approval of its highly anticipated spinal muscular atrophy (SMA) treatment apitegromab. Another is Regeneron, which has two FDA applications pending for eye disease treatment Eylea, which is produced at the site.
In an email, Novo Nordisk acknowledged receiving the OAI status notification on Oct. 9 and said it is in contact with the FDA and its CDMO partners who are affected.
"Ensuring we meet GMP (Good Manufacturing Practices) and Novo Nordisk quality standards is a top priority, and we are enhancing our processes and procedures as part of our commitment to continuous improvement," a company spokesperson wrote.
Friday, Scholar Rock informed investors that the FDA had sent Novo a Form 483, which identifies inspection violations and specifies corrective actions. The Massachusetts biotech also said the FDA had slotted the Bloomington facility into its OAI inspection classification.
Three weeks ago, the FDA rejected Scholar Rock’s application with a complete response letter (CRL), citing manufacturing issues that were not specific to the production of apitegromab.
“We continue to work closely with Novo Nordisk, and we have requested a Type A meeting with FDA to discuss next steps for resubmitting our BLA,” said Scholar Rock, which indicated it would provide more information in its third-quarter earnings presentation next month.
By Monday afternoon, Scholar Rock’s share price had tumbled by roughly 12% compared with its close Friday.
As for Regeneron, the company said on Monday that it also received word from Novo of the OAI. Two months ago, Regeneron revealed the FDA had extended the target decision date for two applications to expand the use of Eylea’s high-dose formulation. The U.S. regulator was originally scheduled to make its Eylea HD decisions by Aug. 19.
The company had already indicated during its second-quarter earnings presentation that the decisions were likely to be pushed back because of issues at the Novo plant.
The company is seeking approval for a chemistry, manufacturing and controls prior-approval supplement for the Eylea HD prefilled syringe, as well as an approval for the drug as a treatment for macular edema following retinal vein occlusion and the broadening of the dosing schedule to include monthly dosing across approved indications.
“The OAI makes further delays likely,” Citi analyst Geoffrey Meacham, Ph.D., wrote in a note to investors. “Notably, if the Catalent Indiana site is still under the OAI status at the time of PDUFA dates, the CRLs will likely be granted.”
Regeneron additionally announced Monday that plans to submit an application by the end of the year for a new filler facility for the production of Eylea HD.
“While this is a positive step toward diversifying manufacturing risk, we note that approval for this alternative facility could take more than 9-12 months, making a near-term resolution from this facility unlikely,” Meacham added.
In a $16.5 billion deal that was completed in December of last year, Novo Nordisk's parent Novo Holdings bought out Catalent. The transaction was accompanied by Novo Holdings’ sale of three Catalent plants—one of them the Bloomington site—to Novo Nordisk for $11 billion.
EDITOR'S NOTE: A statement from Novo Nordisk was added to this story on Oct. 14.