Drugs

Biofrontera sNDA Seeks Expanded Ameluz Use

FDA has accepted for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminolevulinic acid hydrochloride) to include treatment of superficial basal cell carcinoma, a common form of skin cancer. Ameluz is currently approved in the U.S. for treating actinic keratosis, a precancerous skin condition that can progress to invasive disease. The agency set a user fee review action target date of 9/28.

If approved, Ameluz topical gel, used in combination with the company’s RhodoLED red-light lamp, would become the first photodynamic therapy photosensitizer indicated in the U.S. for superficial basal cell carcinoma, according to the company.

Basal cell carcinoma is the most frequently diagnosed cancer in the U.S., with an estimated 3.6 million cases annually, the company says. Published data suggest that between 10% and 25% of those cases are of the superficial subtype, which typically presents as thin, scaly lesions and may be amenable to non-surgical treatment approaches, it adds.

Current standard treatments for basal cell carcinoma often involve surgical excision or other destructive procedures, options that may not be appropriate or desirable for all patients depending on lesion location, cosmetic considerations, or comorbidities, according to the company.

Photodynamic therapy combines a photosensitizing drug with a specific wavelength of light to selectively destroy abnormal cells. Biofrontera says its platform uses a nanoemulsion formulation of aminolevulinic acid designed to enhance skin penetration, followed by illumination with red light, which the company says penetrates more deeply into tissue than shorter wavelengths such as blue or green light.

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