ViiV Healthcare is developing a self-injectable HIV drug similar to Cabenuva; HHS met with insurance companies to resolve COVID-19 vaccine coverage issues; the FDA has greenlit drugmaker Novo Nordisk to add reports of ileus, or intestinal blockage, to its Ozempic label.
Self-Injectable HIV Drug in the Works
ViiV Healthcare, one of the world’s largest commercial developers of HIV drugs, is working on a treatment that can be injected by patients at home every 2 to 3 months, saving them from frequent clinic visits, according to The Guardian. The company is developing a new formulation of its long-acting Cabenuva (cabotegravir/rilpivirine) that will have an autoinjector device to make it safe and easy for patients to self-administer the medication; it hopes to start clinical trials in 2026 and launch treatment by 2030. Cabenuva was first approved in the United States in January 2021, and currently, health care professionals inject it into patients’ buttocks at the hospital every 2 months.
COVID-19 Insurance Hurdles Resolved
On Wednesday, HHS said it had resolved the unexpected insurance issues patients have encountered when receiving updated COVID-19 vaccines from pharmacies, according to NBC News. Some patients were told their insurance would not cover the new shots despite previous claims from federal health officials that they would be provided at no cost for most people with insurance. Consequently, HHS Secretary Xavier Becerra met with leading insurance companies, including UnitedHealth Group and Cigna, to review the progress of the Biden administration’s fall COVID-19 vaccination campaign. According to a rundown of the meeting shared by HHS, the insurance companies assured they are fully covering the new vaccines, describing the denied coverage some patients encountered as systemic technical issues.
FDA Adds Adverse Effect to Ozempic Label
The label for diabetes drug Ozempic (semaglutide), which is also used off label for weight loss, will now acknowledge reports ileus, or blocked intestines, after the FDA greenlit drugmaker Novo Nordisk to make updates, according to CBS News. Ozempic is not the only drug to cause ileus, as weight loss drug Wegovy (semaglutide, Novo Nordisk) and diabetes drug Mounjaro (tirzepatide, Eli Lilly and Company) have acknowledged reports of it on their labels. According to data published by the regulator through June 30, 2023, the FDA has received 8571 reports of gastrointestinal disorders after the use of semaglutide medications, including Ozempic and Wegovy. Of those cases, ileus is specifically mentioned in 33 of them, including that the condition led to 2 deaths. On Thursday, Novo Nordisk made a statement acknowledging Ozempic’s label update, saying the company was working closely with the FDA to continuously ensure the medicine’s safety.