Novo Nordisk's Wegovy, hamstrung by Catalent FDA write-up, could correct by mid-2022

 Worry not, Wegovy fans: There’s reason to believe supply of Novo Nordisk’s obesity med could resume as planned by the middle of the year. That’s according to Jefferies analysts’ chat with a manufacturing expert, who weighed in on the FDA write-up at a Catalent facility behind the production dilemma.

As Novo Nordisk suggested, Catalent could resolve the problems behind Wegovy’s current supply hitch within about six months, followed by some one to two months of FDA follow-up, the manufacturing expert said. Operating on that timeline, production could restart at Calalent’s Brussels filling factory in mid-2022. That would in turn help Novo meet its goal to satisfy Wegovy demand in the U.S. for the second half of the year.

The Wegovy problem is tied to an October inspection of Catalent’s Brussels plant, which ultimately yielded a Form 483. The regulator’s warning letter covered seven observations that knocked Catalent for faulty air filtration systems, “alarming” bacterial growth in a sterile room and more, the Jefferies team wrote in a note to clients Thursday.

Some of those issues were first flagged back in 2017, but remediation efforts only started in 2020 and proved “inadequate,” the Jefferies analysts said. The expert noted that Novo Nordisk should have been apprised of the issues.

With that in mind, none of the issues outlined in the FDA’s Form 483 are “especially challenging” and should be addressable in a six-month timeframe, the expert explained.

“Issues flagged by FDA are numerous and some serious but all can be rectified, as per our expert, with a re-inspection before reopening unlikely,” the Jefferies analysts said.  

The expert flagged two worst case scenarios that could knock Catalent and Novo’s plans off track. Production could face further delays if contamination is found again during test manufacturing, and the source of the contamination is unknown. Secondly, the FDA could also drag its feet to review remediation documents.

“In one case the expert had been involved with, the FDA took 6 months to give the company the go ahead to resume manufacturing,” the Jefferies team noted.

The expert, meanwhile, was “encouraged” by the fact that Catalent shut down its entire Brussels facility, which suggests the CDMO is taking remediation efforts seriously.

Even so, “this Form 483 was viewed to be in the top-25% of worst letters seen (of many 100s),” the Jefferies team said. That heightens “the risk FDA could still issue a Warning Letter in the future should it deem the remediation insufficient or issues recur.”

While details were slim initially, Novo Nordisk in December said that a contract manufacturer in charge of syringe filling for Wegovy pens had temporarily halted deliveries following issues with good manufacturing practices. A Novo Nordisk spokesperson this month confirmed that "the contract manufacturer referred to in the Dec 17 Company Announcement is Catalent.”

Catalent last week told Fierce Pharma it had “received Form 483 observations after a recent FDA inspection of its Brussels sterile filling facility.

“Catalent takes all FDA observations seriously and has made a proactive decision to implement engineering and quality upgrades for the air filtration system," a company spokesperson said via email.

Novo Nordisk, for its part, plans to "relaunch promotional campaigns to raise awareness" among patients and doctors about Wegovy once supply issues have subsided, Doug Langa, Novo's executive vice president of North America operations, said. 

https://www.fiercepharma.com/manufacturing/novo-nordisk-s-wegovy-hamstrung-by-catalent-fda-write-up-could-correct-course-by-mid