Agile Therapeutics Shares Explode as Contraceptive Patch Twirla Gets Nod from FDA

Agile Therapeutics shares were on the rise this week, rocketing nearly 300% after the women’s healthcare company said a U.S. Food and Drug Administration advisory committee voted in favor of its contraceptive patch Twirla.

The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) met to discuss Agile’s New Drug Application (NDA) for Twirla, the company’s lead product candidate.

The committee voted 14 to 1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval.

It was on October 28th that shares tanked after the company said the FDA had issued a document that expresses a number of concerns regarding Twirla’s approvability, and that the FDA didn’t appear to agree with Agile’s proposal to include a limitation of use based on patient weight in the product label.

“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.

Disclaimer: We have no position in Agile Therapeutics Inc. (NASDAQ: AGRX) and have not been compensated for this article.