Agile Therapeutics, Inc. (NASDAQ:AGRX), a women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Twirla® (levonorgestrel/ethinyl estradiol) transdermal system, an investigational combined hormonal contraceptive patch, from November 16, 2019 to February 16, 2020.
On October 30, 2019, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met to discuss the benefits and risks of Twirla and voted 14 to 1, with one abstention, that the benefits of Twirla (AG200-15) in the prevention of pregnancy outweigh the risks to support approval. Although the FDA considers the non-binding recommendation of this panel, the final decision regarding the approval of the product is made by the FDA alone.
After the BRUDAC meeting, at the FDA’s request, Agile submitted additional information to the NDA concerning topics discussed at the BRUDAC meeting. FDA determined that these submissions constitute a major amendment and will take additional time to review. According to FDA’s current PDUFA Performance Goals, an FDA decision to extend the review period typically is limited to situations where review of the new information could address an outstanding issue(s) and potentially lead to approval in the current review cycle.
“We look forward to continuing our discussions with the FDA,” said Al Altomari, Chairman and Chief Executive Officer of Agile. “We remain committed to bringing this important contraceptive option to women.”