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Agile may finally get the go-ahead for its lead asset Twirla after two unsuccessful attempts.
FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, which discussed the NDA for Twirla, voted 14-1 Wednesday that the benefits of Twirls outweigh the risks to support approval. One committee member abstained from voting.
Twirla, or AG200-15, is Agile's investigational, once-weekly combined hormonal contraceptive patch containing a type of estrogen and a type of progestin as active ingredients. It is meant to be applied once a week for three weeks, followed by a week without a patch.
The announcement took the Street by surprise, which was bracing for a negative outcome after a briefing document released ahead of the Adcom verdict relayed concerns of FDA staffers regarding Twirla's efficacy when balanced against its safety.
The panel members were not in agreement with the company's proposal of including a limitation based on patient weight and BMI in the product label, according to the briefing document.
"We are very pleased that BRUDAC voted in favor of Twirla. We look forward to continuing our dialogue with the FDA about the important data presented today and working toward a potential approval of Twirla," Agile CEO Al Altomari said in a statement.
"This vote represents a key step toward providing an important new contraceptive option for women."
The FDA has assigned a PDUFA date of Nov. 16 for Twirla.
The Twirla NDA faced rejection twice before, once in 2013 and the second time in December 2017.
Agile shares, which tumbled by about 76% over Monday and Tuesday in reaction to the briefing document, were soaring 253.48% to $1.31 in premarket trading Thursday.
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