Coartem ® Earns First Priority Review Voucher

The first Priority Review Voucher issued under the Food and Drug Administration Amendments Act of 2007 (FDAAA) was awarded yesterday by the US Food and Drug Administration (FDA) to Novartis Pharmaceuticals Corp. in conjunction with the FDA’s approval for use in the United States of the antimalarial drug Coartem (artemether–lumefantrine) manufactured by Novartis.

The priority review voucher program was created by Congress and implemented by the FDA in September of 2008. The program’s goal is to encourage biopharmaceutical companies to develop novel drugs and biologics to that would prevent and cure a range of tropical diseases that kill millions of patients in the developing world each year. The goal was to create an incentive that would attract industry investment in new medicines for impoverished countries where patients have little if any ability to pay for acceptable health care.

The value of the voucher awarded yesterday to Novartis is that it entitles the recipient to receive a priority review for a future new drug application, potentially shortening the FDA review process to six months from the typical timeframe of ten months or more. If the voucher is applied to a product with substantial sales potential, earlier market entry will reward the company for having invested resources in taking the developing world product through clinical development and registration.

“It is exciting that the first priority review voucher has been issued so quickly after the legislation was enacted and just six months after the FDA formally launched the program,” said Dr. Christopher Earl, president and CEO of BVGH. “PRVs provide a strong incentive for companies to invest in developing new treatments for conditions such as malaria, tuberculosis, African sleeping sickness, dengue fever and other diseases that affect much of the developing world. We applaud Novartis for bringing forward the first PRV-eligible product and the FDA for awarding the first PRV. We believe this is an important step in significantly increasing the pipeline of products for infectious diseases that affect hundreds of millions of the world’s poorest people.”

“Incentives that provide a reward for successfully achieving a public health goal are essential tools for encouraging companies to make investments in global health product development. The inherent value of the vouchers will become clear by enabling rapid review and approval of new products and thereby generating a positive economic return. A series of successes will demonstrate the value of the vouchers, and should attract additional innovators to create novel drugs and biologics for developing world diseases,” said Dr. Leighton Read, General Partner at Alloy Ventures, and a member of the BVGH Board of Directors.

Coartem is a combination therapy comprised of two highly effective antimalarial drugs. Developed in 1996, Coartem is the principal drug recommended for treatment of malaria caused by Plasmodium falciparum – the most deadly species of malaria. Novartis distributes tens of millions of doses per year in the developing world on a no-profit basis. Despite being in use for over a decade, Coartem had not previously been submitted for approval by the FDA.

For detailed information on the priority review voucher program, and updates on FDA’s implementation of the program, visit This website provides background information, news, and key issues surrounding the priority review voucher program.

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