New Gout Drug Gets Nod From FDA
The federal health regulator, the Food and Drug Administration (FDA), gave pharmaceutical giant AztraZeneca the green light to market the gout drug Zurampic (lesinurad) on US soil. The nod marked FDA's 45th drug approval for this year.
Known by its generic lesinurad, gout drug Zurampic shall be used alongside another kind of medication that lowers uric acid production in the body.
The newly-approved medicine helps kidneys release excess amounts of uric acid. Too much uric acid buildup leads to a painful form of arthritis known as gout.
"Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes," told Badrul Chowdhury, head of the Food and Drug Administration's pulmonary, allergy and rheumatology products division as quoted saying by Business Standard.
However, the gout drug wasn't a clear win for AztraZeneca unlike its other drug Targisso which got a solid okay from FDA.
During the deliberation among FDA's experts, the drug only managed to secure a one-vote margin to its favor. Furthermore, FDA required the pharma firm to conduct a heart and kidney safety assesment of Zurampic. AztraZeneca is also told to include text statements advising doctors the risks of kidney failures for some users on the medicine's warning labels according to Fierce Biotech.
In another note, the drug firm also awaits a final decision from European Union (EU) health authorities for the marketing authorization of Zurampic across EU-member countries.
For now, good fortune appears to be in AztraZeneca's favor as European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommends a green light for its new gout drug as mentioned by Medscape.