FDA Approves Hearing Aid Software for AirPods, Tremfya for Ulcerative Colitis, and Grants Breakthrough Therapy Designation to Plozasiran
核心洞察
The FDA has approved over-the-counter hearing aid software for certain Apple AirPods Pro models, demonstrated to provide comparable performance to professionally fitted hearing aids.
Guselkumab (Tremfya) has received FDA approval for treating moderate to severe active ulcerative colitis (搜索) in adults, based on Phase 2b/3 QUASAR study results showing significant clinical remission.
Plozasiran, an investigational RNAi therapy, was granted Breakthrough Therapy designation by the FDA for reducing triglycerides in adults with familial chylomicronemia syndrome (搜索) (FCS).
The FDA has made several significant announcements, including the approval of hearing aid software for Apple AirPods Pro, Tremfya for ulcerative colitis (搜索), and granting Breakthrough Therapy designation to plozasiran. These approvals and designations mark important advancements in treating hearing loss, ulcerative colitis, and familial chylomicronemia syndrome (搜索).
Hearing Aid Software Approved for Apple AirPods
The FDA approved new over-the-counter (OTC) hearing aid software compatible with specific Apple AirPods Pro versions. This software-only mobile medical application, named Hearing Aid Feature, is designed for adults and can be tailored to individual hearing needs. The approval is based on a clinical study involving 118 adults with perceived mild to moderate hearing loss, which demonstrated comparable performance to professionally fitted hearing aids in tests measuring amplification and speech understanding in noise. No adverse events were reported during the study.
Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, stated that this approval advances the availability, accessibility, and acceptability of hearing support for adults with mild to moderate hearing loss.
Tremfya Approved for Ulcerative Colitis
Guselkumab (Tremfya), developed by Johnson & Johnson, has been approved by the FDA for treating moderate to severe active ulcerative colitis (搜索) in adult patients. This marks the third indication for Tremfya, which is already approved for plaque psoriasis (搜索) and psoriatic arthritis (搜索). The approval is based on data from the Phase 2b/3 QUASAR study, which evaluated Tremfya's efficacy and safety in patients with inadequate response or intolerance to conventional therapy, biologics, or JAK inhibitors. The study showed that 50% of patients receiving 200 mg every 4 weeks and 45% receiving 100 mg every 8 weeks achieved clinical remission at week 44.
David T. Rubin, MD, director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, noted that Tremfya significantly improved ulcerative colitis (搜索) symptoms and normalized the endoscopic appearance of the intestinal lining. He added that this approval builds on Tremfya's established safety profile as an IL-23 inhibitor.
Breakthrough Therapy Designation for Plozasiran
Arrowhead Pharmaceuticals announced that the FDA granted Breakthrough Therapy designation to plozasiran, an investigational therapy for reducing triglycerides in adult patients with familial chylomicronemia syndrome (搜索) (FCS). Currently, there are no approved treatments for this rare genetic disease in the United States. Plozasiran is a first-in-class RNA interference (RNAi) therapy designed to reduce the production of apolipoprotein C-III (搜索) (APOC3). Clinical studies have demonstrated reductions in triglycerides and atherogenic lipoproteins, along with a favorable safety profile. The therapy has also received orphan drug and fast track designations. Arrowhead plans to file a new drug application with the FDA this year.
Chris Anzalone, PhD, president and CEO of Arrowhead, emphasized the lack of approved therapies for FCS and expressed optimism that plozasiran's Breakthrough Therapy designation will expedite its availability to patients in need.