Principal deputy commissioner Bumpus agrees with advisory committee findings that safety issues with ITCA 650 preclude approval, regardless of comparisons to other diabetes treatments. Final order caps a nearly eight-year regulatory saga that has grown increasingly rancorous.
The US Food and Drug Administration appears to have closed the door to further debate on the approvability of Intarcia Therapeutics’s ITCA 650, an exenatide implant for type 2 diabetes.
The drug-device combination product’s benefit-risk profile is inadequate to support approval, Principal Deputy Commissioner (PDC) Namandjé Bumpus said.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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