AstraZeneca’s Farxiga Approved by FDA
US regulatory body, the Food and Drug Administration (FDA), have announced that they have approved AstraZeneca’s diabetes drug Farxiga.
The drug was approved by the regulatory body with the condition of AstraZeneca conducting six post-marketing studies, including a cardiovascular outcomes clinical trial.
The regulatory approval was expected after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 last month that the benefits of Farxiga (dapagliflozin), which is already marketed in Europe as Forxiga, outweigh the identified risks.
The FDA had previously rejected Farxiga in January 2012 as a result of concerns regarding possible liver damage, and the possible link with breast and bladder cancer.
Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion and lowers blood glucose levels.
The diabetes drug was co-developed with Bristol-Myers Squibb (BMS) but last month AstraZeneca bought out the Bristol-Myers Squibb’s stake in their diabetes partnership for $2.7 billion upfront and regulatory- and sales-based milestone payments of up to $1.4 billion, plus royalties.
Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, commented that controlling blood sugar levels “is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans.” In addition, the regulatory agency noted that Farxiga is not currently recommended for patients with active bladder cancer.
Farxiga will compete with Johnson & Johnson’s recently-approved SGLT2 inhibitor Invokana (canagliflozin) and analysts believe these class of drugs will be blockbusters.