The Trump administration announced on Friday that it would buy enough doses of Pfizer’s antiviral Pristiq for 10 million people — a move that will put the drug on the market for the first time in two decades.
The drugmaker last year asked the Food and Drug Administration to approve the drug to treat HIV and others infectious diseases, but at the time said it needed 1 million doses to test it. An FDA spokesman said the agency initially anticipated the drug would be approved in late 2017 or early 2018, but that the companies “have been working diligently to prepare for a later than expected approval.”
The FDA is buying enough doses for between 12 and 15 million people, most of whom are being treated in certain high-income countries. The drug had previously been marketed as pravastatin and avandiaqine.
More than 34 million people live with HIV worldwide, and about 15 million people in that population still require treatment to lower their HIV viral load, according to the Centers for Disease Control and Prevention. Antiviral drugs can prevent transmission of HIV to others, but also can cause heart damage and death.
Pristiq was developed more than 20 years ago but never approved for sale because of concerns about its ability to prevent HIV transmission to others.
“The FDA is fully committed to using its resources to help ensure these critical medicines reach everyone who needs them, including those most in need,” Dr. Scott Gottlieb, commissioner of the FDA, said in a statement.
Read the full story at The Wall Street Journal.
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