{"id":144965,"date":"2026-08-13T11:21:24","date_gmt":"2026-08-13T11:21:24","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/144965\/"},"modified":"2026-08-13T11:21:24","modified_gmt":"2026-08-13T11:21:24","slug":"novos-catalent-plant-ditched-in-fda-refiling-of-sma-drug","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/144965\/","title":{"rendered":"Novo\u2019s Catalent plant ditched in FDA refiling of SMA drug"},"content":{"rendered":"

Scholar Rock has shed<\/a> Novo Nordisk\u2019s troubled Catalent facility as a contract manufacturer in its FDA refiling for apitegromab, a candidate for spinal muscular atrophy.\u00a0<\/p>\n

The Cambridge, Massachusetts-based biotech announced the move Friday, while assuring investors of the FDA\u2019s target decision date of Sept. 30.<\/p>\n

The decision comes a year after problems at the legacy Catalent fill-finish facility in Bloomington, Indiana, triggered<\/a> a complete response letter for Scholar Rock\u2019s original application for apitegromab.\u00a0<\/p>\n

The FDA slapped the facility with a Form 483 in July 2025, then escalated it to a warning letter in November.\u00a0<\/p>\n

Since the original snub, Scholar Rock has refiled apitegromab in March 2026, listing two third-party fill-finish facilities, including the \u201cCatalent Indiana LLC\u201d site and another U.S.-based facility \u201cproducing numerous commercial products,\u201d according to its announcement Friday. However, another inspection of the legacy Catalent site in April 2026 again led to<\/a> a Form 483.<\/p>\n

When Scholar Rock CEO David Hallal hopped on the company\u2019s second-quarter earnings call on Thursday, the FDA had not issued an official classification of the April 2026 inspection. At the time, Hallal touted his firm\u2019s optionality, with two available facilities, whichever is found to be the fastest.\u00a0<\/p>\n

That changed on Friday, when Novo alerted Scholar Rock that the agency had issued an \u201cOfficial Action Indicated\u201d (OAI) designation, which indicates serious violations requiring follow-up enforcement.\u00a0<\/p>\n

\u201cWe view this as part of an ongoing process and remain focused on the work already underway to address the agency’s observations, as the quality of the medicines we make\u00a0remains\u00a0a top priority,\u201d a Novo spokesperson said of the OAI in a statement to Fierce Pharma.<\/p>\n

\u201cOver the past year, Novo Nordisk has invested significant resources in improving operations and enhancing quality systems\u00a0at the facility,\u201d the spokesperson added. \u201cSite Bloomington\u00a0remains\u00a0an important part of Novo Nordisk’s operations, and we will continue working collaboratively and transparently with the FDA as we move forward.\u201d\u00a0<\/p>\n

Still, Scholar Rock is shifting all its apitegromab application to the second facility.<\/p>\n

\u201c[T]he FDA review of the facility is advancing, robust supply for commercialization is ready and awaiting packaging and labeling at a third-party site, and importantly, the facility has demonstrated a strong track record of compliance, including recent successful FDA and EMA inspections,\u201d Hallal said of the second plant in an Aug. 7 statement.<\/p>\n

Outside the U.S., Scholar Rock\u2019s application for apitegromab includes only the Catalent Indiana site, as the European Medicines Agency is holding its ruling in anticipation of the FDA\u2019s inspection classification. The company is in discussions with European regulators to potentially use the second fill-finish facility, Hallal said on Thursday\u2019s call.\u00a0<\/p>\n

Before Scholar Rock, Regeneron had to switch manufacturing away from the ex-Catalent facility to overcome an FDA complete response letter<\/a> for the prefilled syringe version of its high-dose Eylea. Regeneron has another recent FDA rejection tied to manufacturing issues at the facility for its CD20xCD3 bispecific antibody, odronextamab.<\/p>\n

The OAI may disrupt regulatory plans for other companies. Issues at the legacy Catalent plant, which Novo inherited as part of Novo Holdings\u2019 acquisition of the CDMO in 2024, recently tripped up<\/a> Incyte\u2019s FDA bid for its PD-1 inhibitor Zynyz in first-line non-small cell lung cancer.\u00a0<\/p>\n

In a statement to Fierce Pharma, Incyte confirmed that \u201cCatalent Indiana is the primary fill-finish manufacturer\u201d for commercial supply of Zynyz, and that it has \u201cnot experienced safety or product quality issues\u201d for marketed products. But the company declined to comment on any plans to refile for the rejected NSCLC indication.\u00a0<\/p>\n

Editor’s Note: The story was edited 1:13 p.m. ET with an update to Incyte’s statement.<\/p>\n","protected":false},"excerpt":{"rendered":"Scholar Rock has shed Novo Nordisk\u2019s troubled Catalent facility as a contract manufacturer in its FDA refiling for…\n","protected":false},"author":2,"featured_media":144966,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[69154,69153,69151,53460,55863,2073,272,17357,69150,69152],"class_list":["post-144965","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-catalent","tag-complete-response-letter","tag-fda-application-process","tag-fierce-biotech-homepage","tag-fierce-pharma-homepage","tag-manufacturing","tag-novo-nordisk","tag-pharma","tag-scholar-rock","tag-spinal-muscular-atrophy"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/117087940603032303","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/144965","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/comments?post=144965"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/144965\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/144966"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=144965"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=144965"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=144965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}