Global Health Policy

Double Bonus: Novartis Antimalarial Coartem Receives Both FDA Approval and First Priority Review Voucher in History

April 16, 2009

Exactly one week ago, the FDA gave the nod to Novartis’ antimalarial drug Coartem, simultaneously granting it the first Priority Review Voucher (PRV) in FDA history. As reported in this blog several times before, the PRV program was enacted by an amendment to FDA law in September of 2007. The amendment gives FDA the authority to award a PRV to the sponsor (company/entity) of a newly-approved neglected disease product application. The fully-tradable voucher can then be used to obtain a priority (6 month) review for another product application of its choosing†.

The value of the voucher is found in the expedited, 6 month review time for the new product, instead of FDA’s standard 10 month review period (which has been known to actually last over a year in many instances). For a potential blockbuster product, this quicker-to-market advantage has been estimated by experts to be worth anywhere from $50 million to $500 million¹². But these figures are nothing but speculation. For the first time, we will be able to track the voucher to see how Novartis chooses to use it and possibly extrapolate its value. Will Novartis sell it to a rival? Will they save countless lives by bringing one of their promising oncology candidates to market faster? A better question is: Will it truly result in an accelerated FDA review? Only time will tell, but we’ll be watching carefully.

†For more information on Priority Review Vouchers, see www.prvinfo.org, run by our colleagues at BIO Ventures for Global Health.

¹ http://prvinfo.org/about/value
² http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/04/fda-approves-coartem-with-priority-review-voucher-voucher-market-is-untested-and-unclear.html