Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions

FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.

Close-up of blue eye. High Technologies in the futuristic. : cataract
Teprotumumab is proposed to treat a rare eye condition called active throid eye disease (TED). • Source: Shutterstock

Several seemingly minor safety issues could complicate the labeling discussions for Horizon Therapeutics PLC's teprotumumab, proposed for active thyroid eye disease (TED), a rare condition.

US Food and Drug Administration assessors did not indicate any of the adverse events mentioned could prevent or delay approval....

More from US FDA Performance Tracker

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

More from Regulatory Trackers

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.