Drugs

Biogen ‘Breakthrough’ Status for Lupus Therapy

FDA has granted Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythematosus (CLE), a chronic autoimmune skin disease for which there are no approved targeted therapies. The designation was based on the totality of data generated to date for litifilimab, including results from the Phase 2 LILAC study, which demonstrated improvements in skin disease activity in patients with CLE compared with placebo, the company says.

Biogen says CLE affects the skin and can occur with or without systemic lupus. Patients often experience rashes, pain, itching and photosensitivity, and the disease can lead to permanent scarring, hair loss and disfigurement that significantly affect quality of life. Current treatment options rely largely on topical steroids, antimalarial drugs and immunosuppressants, which can help manage symptoms but do not alter disease progression.

Litifilimab is described as a first-in-class, humanized IgG1 monoclonal antibody that targets blood dendritic cell antigen 2 (BDCA2), a receptor expressed on plasmacytoid dendritic cells. By binding to BDCA2, the therapy is designed to reduce production of Type I interferons and other inflammatory mediators believed to play a central role in the development of lupus-related skin disease, Biogen says.

“This designation is a significant milestone for litifilimab as we advance the ongoing AMETHYST Phase 3 study,” company executive vice president Priya Singhal is quoted in a release as saying.

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