AstraZeneca Receives Priority Review Voucher from the FDA

AstraZeneca (NYSE:AZN) received good news last Friday, when the U.S. Food and Drug administration approved a new drug for an ultrarare condition linked to anemia and developmental retardation, handing over a priority review voucher to the developer which has been passed on to the company.
According to Fierce Biotech:

The FDA approved Xuriden–the oral uridine triacetate–for a condition known as hereditary orotic aciduria, which is triggered by a breakdown of a key enzyme leading to an accumulation of orotic acid in the urine. According to the FDA, there are 20 known cases of this condition and the drug–a pill used to replace the lost uridine–was tested in four of them in a singe-arm study.
Not much is known about Gaithersburg, MD-based Wellstat, run by Samuel Wohlstadter. The company stopped updating the news section on its website four years ago but put out a press release Tuesday morning noting that they had already agreed to hand over the priority review voucher to AstraZeneca last fall in a deal with undisclosed terms.
A spokesperson for Wellstat told FierceBiotech that the company plans to start selling the therapy itself once it becomes commercially available next year. And the biotech plans to wait until then to announce the price.
Priority review vouchers, a bonus from the FDA that is intended to help encourage the development of new drugs for pediatric and rare conditions, have been an increasingly pricey commodity on the open market.

Click here to read the full article on Fierce Biotech.