The US Food and Drug Administration is likely spending this weekend buying more ink for its "approval" stamp. In the past 7 days, the administration got busy — greenlighting new devices and drugs, putting press on a potential pain therapy, and drawing more attention to a potential new gene therapy.
Here's the MD Magazine
FDA Roundup for the week.
Senhance System, a robotically-assisted surgical device for the facilitation of minimally invasive surgery on adult patients, included 150-patient study data for patients undergoing gynecological procedures that utilized the system.
Ustekinumab (Stelara) has been approved the treatment of adolescents with moderate to severe plaque psoriasis,
marking a significant milestone for adolescents as about one-third of individuals who develop plaque psoriasis do so before the age of 20, and there’s a limited amount of treatment options those 12–18 years of age and older.
The FDA's Dermatologic and Ophthalmologic Drugs Advisory Committee voted favorably for Aerie Pharmaceuticals' netarsudil opthalmic solution .02% for elevated intraocular pressure treatment.
The new formula for Pfizer’s Lyrica — extended-release tablets for the once-daily treatment of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgiamanagement — did not receive an indication for fibromyalgia management, the third of 3 indications sought in its application.
An advisory committee gave unanimous support to Voretigene neparvovec (Luxturna), a proposed treatment for biallelic RPE65-mediated inherited retinal disease that could become the first approved gene therapy for genetic disease.
The Magnetom Terra by Siemens Medical Solutions, Inc., has more than twice the magnetic field strength of the previously highest-rated Tesla MRI device.
The 30-mcg sufentanil sublingual tablet (DSUVIA) by AcelRx Pharmaceuticals received a Complete Response Letter from the FDA, stating the product’s New Drug Application cannot be approved in its current form.
VNS Therapy was approved by the FDA
for drug-resistant epilepsy treatment in patients as young as 4 years old in June. The supplemental SenTiva responsive therapy generator and its accompanying programming system only strengthens the capacity of the therapy.
The stent graft system, developed by Medtronic, allows for a wider range of patients with hostile neck anatomies without renal stenting to be treated. It’s used with the Heli-FX EndoAncher system.
The Remedē System implantable device stimulates diapgrahm-signalling nerves in the chest to aid in the breathing process, and was approved on data showing about half of 141 patients had reported a reduction in apnea hypopnea index by 50% or more.
A non-opioid therapy, the triamcinolone acetonide extended-release injectable suspension is now the first and only such injection available for OA treatment.