Drugs

FDA Approves Pfizer Alopecia NDA

FDA has approved a Pfizer NDA for Litfulo (ritlecitinib), a once-daily oral treatment for individuals 12 years of age and older with severe alopecia areata. The kinase inhibitor is designed to inhibit Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases.

Approval was based on data from the ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with 50% or more scalp hair loss. “In this pivotal study, 23% of patients treated with Litfulo 50 mg had 80% or more scalp hair coverage after six months compared to 1.6% with placebo,” Pfizer says. On the safety side, it says the most common adverse events reported in at least 4% of patients included headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%).

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