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Agile's Phase III Data For Twirla Patch Fall Flat, Raise Doubts On Approval

 
• By Emily Hayes

Twirla low-dose birth control patch doesn't work as well in heavier women in Phase III SECURE study, but Agile believes that this is a class effect and an artifact of the stringent, real-world study design requested by FDA.

Agile Therapeutics Inc. is counting on data from the Phase III SECURE study to support a refiling of its Twirla low-dose combined birth control patch, but the results have raised serious questions about the product's approval prospects and spooked investors.

Agile unveiled top-line results from the SECURE study of 2,032 women on Jan. 3, describing "positive" results for the Pearl...

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More from Complete Response Letters

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By Joseph Haas

Seven weeks before its action date and after a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

More from Product Reviews

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
• By Neena Brizmohun

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.