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Discover the latest FDA-approved treatments, including Dupixent for chronic urticaria and Valtoco for seizure clusters, enhancing patient care options.
From: Regeneron, Sanofi
Dupilumab has received FDA approval for the treatment of adults and adolescents 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic following histamine-1 (H1) antihistamine treatment. In 2 phase 3 clinical trials—Study A and Study C (NCT04180488)—dupilumab demonstrated effectiveness as an add-on treatment to standard-of-care antihistamines in biologicnaive, symptomatic patients with CSU compared with treatment using antihistamines alone. In each trial, key primary and secondary end points with dupilumab were met, with investigators observing significant reductions in both urticaria activity—which is a composite of hives and itch—and itch severity. This marks the first new treatment approved for CSU in more than 10 years.
For more information: dupixent.com
From: Neurelis, Inc
Diazepam nasal spray (Valtoco) was granted FDA approval for the short-term treatment of seizure clusters, also called acute repetitive seizures, among individuals 2 years and older. The approval is supported by data from the phase 1/2a Stellina clinical study (NCT05076838) that evaluated a single dose of diazepam on an as-needed basis as a rescue medication in children aged 2 to 5 years diagnosed with epilepsy. The findings suggest that the safety profile of diazepam nasal spray among pediatric patients was consistent with older patients, supporting its use in children aged 2 to 5 years. The approval of diazepam nasal spray offers additional treatment options for the nearly 3.4 million individuals in the US with epilepsy, including 400,000 children.
For more information: valtoco.com
From: Nampons LLC
Nampons LLC has expanded its retail portfolio, launching Nampons and Nampons Kids at select Walmart locations nationwide, retailers, and Amazon. The products are designed to stop nosebleeds quickly and effectively by gently expanding inside the nose, applying light pressure. Nampons contains a proprietary, patented microdispersed oxidized cellulose that is often used in hospitals by first responders to stop mild bleeding in patients. The company noted increased use of the product among athletes and individuals who experience chronic nosebleeds.
For more information: nampons.com
Compare with: Promacta (Novartis)
From: Camber
Camber has launched eltrombopag, the first generic version of Promacta, indicated for thrombocytopenia and aplastic anemia. Eltrombopag offers a vital treatment option for individuals with these conditions. Thrombocytopenia, characterized by abnormally low platelet counts, can lead to increased bleeding risks, whereas aplastic anemia involves the bone marrow’s failure to produce sufficient blood cells, including platelets. Eltrombopag stimulates the bone marrow to produce more platelets, thereby mitigating the risks associated with these conditions. The availability of a generic version is particularly significant as it promises to increase accessibility and affordability of this crucial therapy for a wider range of patients.
For more information: cambereltrombopag.com
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