The U.S. Food and Drug Administration has approved Pfizer’s Folic Acid Booster Shots for adults age 65 and older, who take over-the-counter medication for heart disease and type 2 diabetes, because they are at higher risk of side effects from such medication.
The company is calling the treatment, which does not include an added dose of vitamin B12 or calcium, as the first drug to treat cardiovascular risk factors that are already considered sufficient to start taking an oral drug.
The approval follows the findings of two large clinical trials that showed the treatment led to fewer stroke-related cases and increased blood flow to the brain in those who received it compared with the control group.
“Older people are more likely to be at increased risk of heart disease, including stroke,” FDA Commissioner Scott Gottlieb said in a statement. “Many of the prescription medicines used to treat cardiovascular disease are also used to treat low blood sugar or type 2 diabetes, so it’s important to give Folic Acid Booster Shots to older people who may be at greater risk.”
According to the statement, the FDA reviewed information from clinical trials with more than 9,000 participants. The drug has been on the market in parts of Europe since 2008 and in Israel since 1987. Pfizer has been marketing the treatment in Canada since 2013 and in Brazil since 2010.
The average U.S. cost for a month’s supply of the drug, according to Pfizer, is $35.60.