(RTTNews) - After two failed attempts to secure FDA approval, Agile Therapeutics Inc.'s (AGRX) lead product candidate, Twirla, an investigational combined hormonal contraceptive patch, is now all set to face the regulatory agency for the third time on November 16, 2019.
Yesterday, the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the FDA, which reviewed the Company's New Drug Application for Twirla has overwhelmingly recommended approval of the product candidate.
The Committee has voted 14 to 1, with 1 abstention, in favor of approval.
Twirla is a 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.
Agile Therapeutics has been pursuing FDA approval for Twirla since 2012.
The U.S. regulatory agency denied approval for the drug in February 2013, and the Company was asked to conduct a new clinical trial and provide additional information on the manufacturing process for the hormonal contraceptive patch.
Agile Therapeutics' second attempt in 2017 to get FDA nod for Twirla was also futile as in December of that year, the regulatory agency issued a Complete Response Letter and refused to approve the drug again, citing deficiencies relating to quality adhesion test methods and deficiencies in a facility of the Company's third-party manufacturer, Corium International Inc. (CORI).
Addressing the concerns raised in the 2017 Complete response Letter, the Company resubmitted the Twirla NDA in May of this year.
Now that Twirla has cleared the penultimate regulatory hurdle of the FDA panel review, it just has one more step, ie., the final FDA decision, to make it to the finish line.
The regulatory agency usually follows the panels' recommendation although it is not mandatory to do so.
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