FDA Roundup: Agency Highlights From June 2024

FDA Approves Ensifentrine for Treatment of COPD

The FDA approved ensifentrine (Ohtuvayre) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients, Verona Pharmaceuticals announced in a release. The medication is the first inhaled product with a novel mechanism of action approved to treat COPD in over 20 years.

FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive

The FDA approved Merck’s Capvaxive (V116), Merck’s pneumococcal 21-valent conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older. Approval for Capvaxive was based on clinical data from the pivotal phase 3 STRIDE-3 trial (NCT05425732.

FDA Approves Dapagliflozin to Treat Pediatric Patients with Type 2 Diabetes

The FDA approved dapagliflozin (Farxiga) to improve glycemic control in pediatric patients aged 10 years or older with type 2 diabetes (T2D), AstraZeneca announced in a release. The therapy, which is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, was previously approved for adults with T2D as an adjunct to diet and exercise.

FDA Approves 2 New OTC Continuous Glucose Monitors

The FDA provided clearance to 2 over-the-counter (OTC) continuous glucose monitor (CGM) systems, health care technology company Abbott announced in a release. The new OTC devices are based on the company’s FreeStyle Libre sensing technology, which is the most widely used CGM system in the world.

FDA Advisory Panel Votes Against MDMA-Assisted Therapy for PTSD

An independent FDA advisory panel voted against the use of midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) during a meeting, saying the treatment was not effective at treating the condition and that the benefits don’t outweigh risks associated with the drug.

Discussing the FDA Panel’s Rejection of MDMA-Assisted Therapy for PTSD

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses problems that he saw with the FDA advisory panel, the issue of functional unblinding, stereotypes of psychedelics being gateway drugs, and the fact that patients with PTSD desperately need new treatment options.

FDA, DOJ Launch Multi-Agency Task Force to Address Illegal E-Cigarettes

In response to the concerning trend of e-cigarette use among youth, the US government is taking a major step to fight the illegal sale and distribution of the devices. A new federal task force will combine the resources of multiple agencies to investigate, prosecute, and seize illegal e-cigarettes, of which pose unique and significant harm to the demographic.

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