Argenx purchases $100M+ FDA priority review voucher from bluebird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

“With a priority review voucher available, we hope to expedite the approval process for one of our current or future indications to more quickly reach the patients who are in serious need of a new treatment option,” he added.

Just last week, argenx filed for approval of a subcutaneous version of Vyvgart (the original is administered by IV) in gMG. The FDA has already granted the drug a priority review, though, with an expected decision date of March 20.

Andrew Obenshain

Bluebird won two PRVs this year from its approvals of Zynteglo in beta-thalassemia and Skysona in early, active cerebral adrenoleukodystrophy. While the first sale has yet to be finalized, CEO Andrew Obenshain is already considering selling the second PRV.

“As momentum builds across our business, this non-dilutive capital further bolsters the ongoing launches of our two recently approved gene therapies and the execution of near-term, value-creating milestones, including the planned submission and subsequent FDA review of our biologics licensing application for lovo-cel for sickle cell disease,” he said.

This isn’t argenx’s first time around the PRV block. The company bought one from Bayer in 2020 for $98 billion, which Bayer had won for its approval of Lampit in pediatric Chagas disease.

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