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Agile Therapeutics to meet FDA committee in October to review NDA for Twirla

There’s great excitement about the Twirla low-dose contraceptive patch as the FDA has previously assigned a November 16 PDUFA action date

Agile Therapeutics' Twirla
Oppenheimer predicts the Twirla contraceptive patch could drive sales of $250 million to $300 million

Agile Therapeutics Inc (NASDAQ:AGRX) said its executives will meet with the US Food and Drug Administration’s advisory committee in October to review the company’s New Drug Application (NDA) for its lead product candidate Twirla.

Executives will meet with members of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee on October 30 to review the NDA for Twirla — a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch.

READ: Oppenheimer initiates Outperfrom rating on Agile Therapeutics, sees FDA approval of Twirla contraceptive

The Princeton, New Jersey-based women’s health-care company announced last month that the FDA has accepted for review its new drug application resubmission for Twirla. The company had originally submitted an application for FDA approval in June 2017, but the agency kicked it back and asked for more data.

Agile resubmitted the NDA for Twirla (AG200-15) on May 16, 2019 and the FDA has assigned a Prescription Drug User Fee Act action date of November 16, 2019 for the completion of its review of Twirla.

Earlier this month, analysts at Oppenheimer said Agile appears to have settled its issues with the FDA and Twirla could be a big revenue-maker for the company.

“We look forward to the October 30, 2019 meeting with the advisory committee, as well as to continuing our dialogue with the FDA about Twirla and the important data, which we believe supports its approval,” said Agile Therapeutics CEO Al Altomari. “This is another key step towards providing an important contraceptive option for women today.” 

Currently there’s only one US government-approved contraceptive patch available to women — Xulane, which is produced by Mylan Pharmaceuticals Inc (NASDAQ:MYL).

Analysts expect Twirla to have safety advantages to Xulane, given the latter’s issues with high estrogen levels. They also think women will find Twirla more user-friendly than Xulane, which had gross sales of $271 million in 2018.  

Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. The company has eight patents covering Twirla. Its active ingredients are ethinyl estradiol, a type of synthetic estrogen, and levonorgestrel, a type of progestin.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive 

Quick facts: Agile Therapeutics

Price: 2.75 USD

Market: NASDAQ
Market Cap: $240.45 m

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Agile Therapeutics looks forward to Feb 16 PDUFA date

Agile Therapeutics (NASDAQ:AGRX) CEO Al Altomari sat down with Proactive’s Christine Corrado at the Biotech Showcase 2020 in San Francisco. New Jersey-based Agile is focused on seeking FDA approval of its lead drug Twirla, and is looking forward to its Feb 16 PDUFA date

on 01/14/2020

2 min read