Regulatory Focus™ > News Articles > With New Data in Hand, Could Sanofi and Regeneron Use a Regulatory Shortcut?

With New Data in Hand, Could Sanofi and Regeneron Use a Regulatory Shortcut?

Posted 16 March 2015 | By Alexander Gaffney, RAC

With New Data in Hand, Could Sanofi and Regeneron Use a Regulatory Shortcut?

A new drug being co-developed by drugmakers Sanofi and Regeneron could, according to new data, dramatically decrease low-density lipoprotein (LDL) cholesterol in patients and lessen cardiac events. But it's a reduction in something else that could be most important for Sanofi and Regeneron: the time it might take the US Food and Drug Administration (FDA) to review the new drug, Praluent.


In July 2014, Sanofi and Regeneron announced they had purchased what is known as a Rare Pediatric Priority Review Voucher from BioMarin, which had received the voucher from FDA in February 2014 upon the approval of its rare disease drug Vimizim.

The companies paid $67.5 million for the voucher—then a record-setting sum, if only because it was the first priority review voucher to ever be sold by one company to another.

At the time of purchase, Sanofi and Regeneron said they planned to use the voucher to support the expedited approval of Praluent, then known by its nonproprietary name alirocumab.

What's a Priority Review Voucher?

The voucher is potentially highly valuable to both companies. FDA allows the recipient of a priority review voucher to get any drug it wants reviewed by FDA in just six months under FDA's "priority review" program.

Read our extensive Regulatory Explainer about FDA's priority review voucher programs here.

Use of the voucher has both potential benefits and pitfalls.

From a benefits perspective, use of the voucher could bring a product to market more quickly, helping both patients and Sanofi and Regeneron's revenue streams. And since FDA's traditional review process takes 10 months (in "FDA time," which does not include time taken to request additional information) to complete, a six-month priority review could even potentially extend the amount of time the companies have to market their drugs under existing patent protections.

Major Risks to Priority Review

However, there are major risks as well. Each voucher costs $2,562,000 to use, and there is no guarantee FDA will actually approve the drug. FDA has awarded five priority review vouchers in its entire history, but the only company to redeem its voucher, Novartis, saw its drug rejected.

Once a voucher is used on a review, it cannot be redeemed again. In other words, if Sanofi and Regeneron use their voucher but fail to obtain approval, they would be out the cost of the voucher ($67.5 million), the cost of a new drug application filing ($2,335,200) and the cost of the priority review ($2,562,000)—a whopping $72.4 million.

Then there are the risks of perception—that by granting a voucher request, FDA could be seen as rushing its review of a drug in a “pay-to-play”-type arrangement. Companies might prefer to have their drugs undergo a slightly longer, cheaper process that gives the public more faith in the outcomes of FDA's review process and their drug.

For Sanofi and Regeneron, then, this could be a high-stakes regulatory submission. The rewards of success could be high, but so too would be the costs of failure.


Press: New Praluent Data

Categories: Regulatory News

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