PRV

Sanofi announced Monday that the U.S. FDA has approved its oral sleeping sickness treatment, fexinidazole, in patients age 6 and older and weighing at least 20 kilograms. According to the press release, the approval also nets a tropical disease Priority Review Voucher for Sanofi’s co-developer, the Drugs for Neglected Diseases Initiative. Sanofi and DNDI will share the PRV benefits.

The EMA approved the drug in 2018.

Two U.S. FDA priority review voucher (PRV) transactions took place over the last week: New York-based cancer antibody developer Y-mAbs Therapeutics sold its voucher to Maryland biotech United Therapeutics for $100 million, and Boston-based companies Alexion and Rhythm Pharmaceuticals reached a $105 million deal for Rhythm’s PRV.

The data points suggest PRV values may have stopped falling from their 2015 high of $350 million after consistent pricing over the past year of approximately $…

Two U.S. FDA priority review voucher (PRV) transactions took place on Monday: Belgian immunology specialist Argenx paid $98 million to Bayer for the pharma giant’s voucher and California-based Eiger BioPharmaceuticals sold its voucher to an undisclosed buyer for $95 million.

PRVs are now routinely selling for less than one-third of their 2015 high of $350 million, according to data monitored by Duke University’s David Ridley, a creator of the PRV program.

The U.S. FDA on Wednesday approved Regeneron’s triple-antibody cocktail (REGN-EB3) for the treatment of Zaire ebolavirus in adults and children. Now branded as Inmazeb, the mixture of monoclonal antibodies becomes the first FDA-approved treatment for the disease.

The approval brings the New York-based company a priority review voucher and an estimated $335 million under a previously announced contract to supply the U.S. government.

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The U.S. FDA has awarded Priority Review to Regeneron’s Ebola-fighting monoclonal antibody treatment, REGN-EB3, the company announced last week. The triple-antibody cocktail, which boasts FDA Breakthrough Therapy and orphan drug designation, should receive a decision on approval by October 25, the company’s press release said.

Approval would land Regeneron a priority review voucher (PRV), which the New York-based company could sell or use to accelerate licensing of another product.…

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The U.S. Government Accountability Office issued a report last month questioning the impact of FDA priority review vouchers (PRVs) because of a lack of evidence that the incentive is acting as intended and due to falling PRV resale prices as the FDA awards them more frequently.

However, several drug sponsors—including Janssen, Medicines Development for Global Health, Novartis and Sanofi—told the researchers that they disagreed and that the opportunity to earn a PRV did factor into…

Aruvant Sciences announced last week that the U.S. FDA has granted Rare Pediatric Disease designation to ARU-1801, its investigational sickle cell disease therapy. The company could win a Priority Review Voucher to use for another product or sell if the FDA approves the treatment.

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Merck announced last month that the U.S. FDA has approved its Ebola vaccine Ervebo, earning the company a tropical disease priority review voucher that it can use to accelerate licensing of another of its products, or sell.

The shot won WHO prequalification and European Commission conditional marketing authorization in Q4 2019.

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Bavarian Nordic announced yesterday that it has sold its U.S. FDA priority review voucher (PRV) to an undisclosed buyer for $95 million. The company won the voucher in September for its live, nonreplicating smallpox and monkeypox vaccine.

PRVs on the secondary market have been selling at a discount in recent years, following a record high of $350 million paid by AbbVie in 2015.

Novartis announced last week that the U.S. FDA has approved its sickle cell disease (SCD) treatment for patients aged 16 years and older. The monoclonal antibody earned an FDA Priority Review in July after positive Phase 2 trial results showed it reduced the median annual rate of SCD pain crises by 45 percent. With the approval, the company wins both a priority review voucher and orphan drug designation. Novartis acquired crizanlizumab in 2016 in its $665 million buyout of Selexys…