FDA Roundup: Agency Highlights from September 2024

FDA Approves Dupixent as First Biologic Treatment for COPD

he FDA has approved dupilumab (Dupixent) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, Sanofi announced in a release. The decision makes dupilumab the first biologic medicine approved in the United States to treat the lung disease.

Schizophrenia Drug Approved by FDA Represents First New Treatment Option in Decades

The FDA approved xanomeline and trospium chloride (Cobenfy, formerly KarXT), an oral medication for the treatment of schizophrenia in adults, Bristol Myers Squibb announced in a release. The approval marks a breakthrough in the treatment for the condition, as xanomeline and trospium chloride represents the first new class of medication for schizophrenia in decades.

FDA Approves Levacetylleucine for Treatment of Niemann-Pick Disease Type C

The FDA approved levacetylleucine (Aqneursa) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients who weigh 15 kg or more, IntraBio said in a release. The decision makes levacetylleucine the first stand-alone therapy for the disease approved in the United States.

FDA Approves FluMist as First-Ever Self-, Caregiver-Administered Flu Vaccine

Nasal spray flu vaccine FluMist has been approved by the FDA for self- or caregiver-administration, according to an agency news release. It is approved for the prevention of the flu caused by influenza virus subtypes A and B and is indicated for use in individuals aged 2 to 49 years.

FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis

The FDA has approved benralizumab (Fasenra) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adult patients, AstraZeneca announced in a release. The decision makes the therapy the second approved to treat the rare disease in the United States, with the other being GSK’s mepolizumab (Nucala).

FDA Approves Lebrikizumab-lbkz for Moderate-to-Severe Atopic Dermatitis

The FDA has approved Eli Lilly and Company’s lebrikizumab-lbkz (Ebglyss), a targeted IL-13 inhibitor for the treatment of moderate-to-severe atopic dermatitis that is not well controlled by topical prescription therapies in adults and children 12 years of age and older who weigh at least 88 pounds, the company announced in a release.

FDA Approves First-Ever OTC Hearing Aid Software

The FDA has authorized the first OTC hearing aid software, Hearing Aid Feature (HAF), according to an agency release. Designed for Apple AirPods Pro headphones, this medical application allows compatible models to function as hearing aids for adults aged 18 and older with mild to moderate hearing loss. Users can benefit from amplified sounds tailored to their specific needs after installation and personalization.

FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder

The FDA has granted clearance to the digital therapeutic DaylightRX for the treatment of generalized anxiety disorder (GAD) as an adjunct to usual care in patients aged 22 years and older, Big Health announced in a release. The therapy is the first digital treatment approved to treat GAD in the United States.

FDA Clears New Disposable Insulin Patch Pump for Patients With T1D and T2D

Embecta has received 510(k) clearance from the FDA for its proprietary disposable insulin delivery system indicated for adults with type 1 (T1D) and type 2 diabetes (T2D) and informed by feedback from people with T2D, the company announced in a release.

FDA Approves Updated Novavax COVID-19 Vaccine

The FDA has granted emergency use authorization (EUA) to an updated COVID-19 vaccine from Novavax to prevent the disease in individuals aged 12 years and older, the company announced in a release. Novavax said the vaccine will be available in thousands of pharmacies and grocers across the United States after batches are released by the Center for Biologics Evaluation and Research.

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