Biologics

Revance BLA Shot Down Over Inspection Findings

FDA has issued Revance Therapeutics a complete response letter on its BLA for daxibotulinumtoxinA for Injection and its use in treating moderate to severe glabellar (frown) lines. The letter, according to the company, said the agency was unable to approve the submission due to deficiencies related to an onsite inspection at Revance’s manufacturing facility. It plans to request a Type A meeting with FDA as soon as possible to address the deficiencies raised. No other deficiencies were identified in the CRL.

Earlier this month, FDA released a 7/2 FDA-483 with five inspection observations issued following a 6/21-7/2 inspection at the firm’s Newark, CA drug substance and drug product manufacturing facility. The inspection observations were:

current release and stability cell bank testing methods are insufficient to monitor quality and shelf-life of working cell bank;
the current manufacturing process is not the process proposed for licensure;
the firm’s quality unit lacks the responsibility and authority for the control, review, and approval of outsourced activities, which includes defining the responsibilities and communication processes for quality-related activities in a written agreement;
actual yield and percentages of theoretical yield, indicators of process performance, are not determined after each appropriate phase of manufacturing for a redacted drug product; and
the responsibilities and procedures applicable to the quality control unit are not always in writing.

DaxibotulinumtoxinA is the company’s next-generation neuromodulator product that “combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components,” Revance says. DaxibotulinumtoxinA is also being evaluated in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications — cervical dystonia and adult upper limb spasticity.

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