FDA Roundup: Agency Highlights from August 2024

Omnipod 5 FDA Cleared for Use in Adults With Type 2 Diabetes

Following FDA clearance, the Omnipod 5 Automated Insulin Delivery System is now indicated for use in adults with type 2 diabetes and is the first and only automated insulin delivery system that is FDA cleared for use in the management of both type 1 and type 2 diabetes.

COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations

The FDA approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines manufactured by Moderna and Pfizer to include a monovalent component corresponding to the KP.2 variant of the Omicron strain of SARS-CoV-2. These vaccines, the FDA noted in a news release, now “more closely target currently circulating variants and provide better protection against serious consequences of COVID-19.”

Amneal Pharmaceuticals Receives FDA Approval for Propofol Injectable Emulsion Single-Dose Vials

The FDA granted Amneal Pharmaceuticals an Abbreviated New Drug Application (ANDA) approval for its propofol injectable emulsion USP, 200mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1000 mg/100 mL (10 mg/mL), single-dose vials. With FDA approval in tow, Amneal’s product could help mitigate current supply restraints and ensure that hospitals have access to the medication they need.

FDA Grants Tentative Approval to Treprostinil for PAH Associated With PH-ILD

The FDA granted tentative approval of treprostinil (Yutrepia) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The tentative approval of treprostinil is supported by findings from the phase 3, open-label, multicenter INSPIRE trial.

FDA Grants Marketing Authorization to First-Ever OTC Syphilis Test

The FDA granted marketing authorization to NOWDiagnostics for its First To Know Syphilis Test, the first at-home, OTC test to detect Treponema pallidum (syphilis) antibodies in human blood. Requiring just a drop of blood, the rapid test delivers results in approximately 15 minutes and can help individuals make informed decisions about seeking further care for the sexually transmitted infection (STI).

FDA Approves Medtronic’s Disposable CGM

The FDA approved a new disposable continuous glucose monitor (CGM) from medical device company Medtronic. The Simplera is an all-in-one CGM that is half the size of the company’s previous devices, which allows for easier insertion and a simplified wear experience without the need for overtape. The Simplera CGM is meant to be used as part of a smart multiple daily injection system, which features the company’s smart insulin pen InPen and the Simplera Sync sensor.

FDA Approves First Monoclonal Antibody to Treat Prurigo Nodularis

The FDA has approved nemolizumab (Nemluvio) for the treatment of prurigo nodularis in adult patients. The therapy inhibits the signaling of IL-31 and comes in a pre-filled pen that is intended for subcutaneous injection. It is the first monoclonal antibody approved to treat the chronic skin condition. The approval of nemolizumab was based on data from the phase 3 OLYMPIA 1 and OLYMPIA 2 clinical trials.

FDA Approves First Treatment for Hypoparathyroidism in Adults

The FDA approved palopegteriparatide (Yorvipath) for the treatment of hypoparathyroidism in adults. The therapy is the first and only approved treatment in the United States for hypoparathyroidism, a rare endocrine disease that lowers the levels of calcium and increases levels of phosphorus in the blood. The disease occurs when 1 or more parathyroid gland is not active and affects 70000 to 90000 people in the country.

FDA Rejects MDMA-Assisted Therapy to Treat PTSD in Setback for Psychedelic Medicine

The FDA has issued a complete response letter (CRL) to a new drug application (NDA) for midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults. The decision, which would have made MDMA-assisted therapy the first psychedelic-assisted therapy available in the United States if it was approved, marks a significant setback for the psychedelic medicine community.

FDA Approves Nalmefene Injection for Opioid Overdose

The FDA has approved nalmefene injection (Zurnai) for the emergency treatment of known or suspected opioid overdose caused by natural or synthetic opioids in adult and pediatric patients aged 12 years and older. Nalmefene injection received both fast track and priority review designations.

FDA Grants Accelerated Approval to First Engineered Cell Therapy for Synovial Sarcoma

The FDA has granted accelerated approval to Adaptimmune Therapeutics for afamitresgene autoleucel (afami-cel [Tecelra]). The drug is indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

FDA Approves First Needle-Free Epinephrine Nasal Spray

ARS Pharmaceuticals has received approval from the FDA for its epinephrine nasal spray (neffy) for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds. The therapy had previously been granted Fast Track Designation.

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