All Signs Pointing to FDA Approval for Agile Therapeutics’ Twirla

Posted on January 07, 2020 by Medtech[y] Staff

It’s been a long and winding road for Agile Therapeutics and their quest in getting their birth-control patch, Twirla, FDA approved, but the final destination of FDA approval looks to be closer than ever before.

Twirla, also known as AG200-15 is an investigational, once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), a type of estrogen, and levonorgestrel (LNG), a type of progestin.

Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. Agile has completed its Phase 3 clinical trials of Twirla and is pursuing regulatory approval in the U.S. after resubmitting a New Drug Application (NDA) for Twirla on May 16, 2019.

In October 2019, Agile Therapeutics had a very favorable AdCom, with the BRUDAC voting 14 to 1 in favor of Twirla. The FDA set a PDUFA (Prescription Drug User Fee Act) date of November 16, 2019, but then the FDA extended that date to February 16, 2020.

The extension initially alarmed investors and was not expected as approximately 80% of positive AdCom voting results in FDA approval.

The extension is likely to work with Agile on the labeling of Twirla, but the extension clearly should cause some concern.

With that said, there are a couple of strong pieces of evidence that should make investors feel confident in FDA approval on or before the expected PDUFA date.

For one, Agile recently hired two key positions which will be required once Twirla gets FDA approval. If the company didn’t feel confident in Twirla's chances, they wouldn’t have committed the resources prior to knowing the outcome.

“We remain focused on seeking FDA approval of Twirla and building a robust women’s health company. We continue to make strategic investments and build our team to achieve those goals,” said Al Altomari, Chairman and Chief Executive Officer of Agile.

Additionally, until today, Agile was only scheduled to present at the Biotech Showcase in San Francisco on January 14th as they didn’t make the cut for the J.P. Morgan Healthcare Conference which is scheduled for the same week.

It would make sense for a company that’s expected to get FDA approval for an exciting new product be on the schedule at JPMorgan, at least later in the week in one of the less attractive timeslot.

Well, in a change of events, Agile announced today that they will in fact be presenting at J.P. Morgan on Thursday January, 16 at 10:30 AM.

It wouldn’t make sense for J.P. Morgan to add Agile to the conference if Twirla wasn’t likely to be approved, and also with too restrictive of a label.

While nothing is official until Agile gets the nod from the FDA on their decisions, all of the evidence is pointed towards approval for Twirla.

The decision can come on or before February 16 which is a reason why Agile’s stock has climbed from $1.20 on October 31, 2019 to its current price of 2.85.