Therapeutic Talk: Menopause Gets a New Drug Type
The FDA has given the green light to a new type of drug said to relive the hot flash and night sweats symptoms of menopause. Astellas Pharma developed Veozah, or fezolinetant, a neurokinin 3 (NK3) agonist that blocks receptors in the brain that play a role in regulating body temperature. Traditionally, symptoms of menopause have been ignored or, in severe cases, treated with hormone replacement therapy. Veozah offers an effective alternative to this treatment, especially for women who should not undergo hormone replacement therapy due to their increased risk of blood clotting and cancer. Clinical trials for the drug included more than 3,000 women across the U.S. and Canada, and was said to reduce the number of hot flashes women experienced each week significantly more than a placebo after taking the drug for a year. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” stated Janet Maynard, MD, MHS, Director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine in the Center for Drug Evaluation and Research. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”
Med Device Department: The Newest Weight Loss Balloon Also Has an App
Allurion received FDA go ahead for its new weight loss tech and now it signed a deal with Medtronic to bring its device around the world. The company’s swallowable gastric balloon and AI partner program will be offered through Medtronic’s existing sales channels in Central and Eastern Europe, the Middle East, and Africa during a 12-month pilot agreement. Allurion’s weight loss program centers around its newest technology—a gastric balloon that is swallowed in pill form and inflates when in the stomach. It stays inflated in the stomach and curbs hunger for about four months, during which time patients can monitor their weight loss and are guided through behavior-changing processes using the company’s Iris AI program in the form of a mobile app, a connected scale, and health-tracking smartwatch. The balloon naturally deflates after four months and exits the body on its own, avoiding the need for intrusive surgery for bariatric devices. HCPs are also able to keep track of patients’ progress via the Iris AI platform, which can predict the outcome of each patient’s weight-loss regimen. The platform and hardware are available separate from the Allurion balloon as well. In February 2023, Allurion announced plans to take its company public by entering a collaboration with special purpose acquisition company (SPAC) Compute Health Acquisition Corp., in a deal that values the resulting combined company at $500 million. Medtronic is one of the investors in the SPAC.
DC Dispatch: Novo Nordisk Cracks Down on Unauthorized Ozempic and Wegovy
After the FDA’s warnings that some pharmacies are developing unauthorized versions of the wildly popular diabetes and obesity drugs Ozempic and Wegovy, Novo Nordisk is taking action with lawsuits in Florida, New York, Tennessee, and Texas. The company is charging health spas, clinics, and pharmacies with false advertising, trademark infringement, and unlawful sales of compounded versions of Ozempic and Wegovy, as stated in a press release. While some pharmacies are permitted to make compounded versions of the drugs in areas of supply shortages, some are making compounds without the key ingredient, semaglutide, in an attempt to keep up with the popularity of the drugs as weight loss tools despite their indications for diabetes and obesity. According to the FDA, some companies are using semaglutide sodium or semaglutide acetate instead, which have not been proven to be safe or effective. Novo Nordisk is also cracking down on medical spas for false advertising by not informing patients they are getting a compound version of the brand’s drugs. “These unlawful marketing and sales practices, including the use of Novo Nordisk trademarks in connection with these practices, have created a high risk of consumer confusion and deception as well as potential safety concerns,” the company stated in the release. In response, the company has launched semaglutide.com to provide information about the responsible use of the company’s treatments for U.S. audiences.
FDA Update
Drug Approvals
The FDA approved the first oral treatment for Crohn’s disease in patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Rinvoq (upadacitinib) has been developed by AbbVie to treat the chronic inflammatory bowel disease that causes inflammation in the digestive tract. The FDA approved Linzess (linaclotide) capsules to treat functional constipation in pediatric patients 6 to 17 years of age. The 72-mcg dose oral medication is the first drug approved to treat this condition. The common condition is classified by painful, infrequent stool passing without underlying cause. AbbVie and Ironwood Pharmaceuticals’ Linzess has been previously approved for irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) in adults. The first oral anti-viral treatment for COVID-19 in adults has now been approved by the FDA. Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir) oral tablets are for adults who are at high risk for progression to severe COVID-19, including hospitalization or death. The treatment has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA). A new treatment developed by Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics, has been FDA approved for treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, in patients 18 years of age and older. Xacduro (sulbactam; durlobactam) is an injection that uses sulbactam to kill A. baumannii while durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii. Xacduro is administered by intravenous infusion. The Acinetobacter species top the WHO’s list of critical bacterial pathogens that pose the greatest threat to human health. The FDA has approved a treatment developed by Braeburn that offers a new treatment for opioid use disorder. Brixadi (buprenorphine) extended-release injection for subcutaneous use treats moderate to severe opioid use disorder and is available in two different forms. Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine.
Med Device Approvals
ImageBiopsy has received FDA clearance for IB Lab LAMA, the first fully automated radiological image processing software for geometric length and angle measurements of the lower limb on full leg X-rays. The FDA previously cleared the company’s IB Lab KOALA Knee-Osteoarthritis Labeling Assistant. In both cases, IB Lab expedites image-based workflows of surgeons and radiologists by combining deep learning technology and state of the art software engineering to provide fast, accurate, and standardized radiological musculoskeletal parameters on X-rays.
