Drugs

FDA Offers Path Forward for Twirla NDA

Although it denied an Agile Therapeutics formal dispute resolution request involving a decision by the CDER Division of Bone, Reproductive, and Urological Products (DBRUP) that Agile’s Twirla could not be approved due to concerns about its in vivo adhesion properties, the CDER Office of New Drugs (OND) proposed a path forward for the company without having to reformulate Twirla or conduct a bioequivalence study between formulations. Twirla (levonorgestrel/ethinyl estradiol transdermal system) is described as an investigational low-dose, once-weekly contraceptive patch. A 12/21/17 complete response letter said Twirla could not be approved in its present form due to deficiencies related to quality adhesion test methods, observations identified during a pre-approval inspection at the product’s manufacturing facility, and because of adhesion property questions.

OND suggested that Agile conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane, the generic version of the previously marketed Ortho Evra contraceptive patch. OND recommended that the company meet with DBRUP staff to get agreement on the specific design and success criteria of a wear study.

“We appreciate the constructive discussions we’ve had with FDA during this formal dispute resolution process,” Agile CEO Al Atomari said. “We are pleased that OND has provided a path forward and we plan to meet with the division to discuss the specifics of the proposed wear study as soon as possible.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome