Biologics

FDA Approves Daxxify for Frown Lines

FDA has approved a Revance Therapeutics BLA for Daxxify (daxibotulinumtoxinA-lanm) for injection for temporarily improving moderate-to-severe frown lines (glabellar lines) in adults. The product, which will compete against Allergan’s Botox, is being touted as the first long-acting neuromodulator that “demonstrates a median duration of six months and up to nine months for some patients,” according to the company. It says conventional neuromodulators have a three- to four-month duration profile.

Approval was based on data from the SAKURA Phase 3 clinical trial program (SAKURA 1,2,3), that involved more than 2,700 patients and about 4,200 treatments. Data showed that 74% of treated patients achieved a greater than two-grade improvement in glabellar lines at week four as assessed by both the patient and clinical investigator, Revance says. It also showed that 98% of subjects achieved none or mild wrinkle severity at week four 4 (investigator assessments).

The company says data showed that Daxxify is safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials, and “has a safety profile consistent with other currently available neuromodulators in the esthetics market. The most common treatment-related adverse events with Daxxify observed in the pivotal trials were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).”

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