Product News: September 2024

RX Products

Donanemab-azbt (Kisunla)

Manufactured by: Eli Lilly and Company

Image credit: Kwangmoozaa | stock.adobe.com

The FDA has approved donanemab-azbt to treat early-stage symptomatic Alzheimer disease (AD) in individuals with mild cognitive impairment and those in the mild dementia stage of AD who have confirmed amyloid pathology. The drug is administered once monthly via an intravenous infusion and is the first and only amyloid plaque–targeting therapy that supports stopping therapy when the plaque is removed. The approval was based on results from the phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511), which displayed significantly slowed clinical progression at week 76 among individuals treated with donanemab-azbt. Additionally, of the 24 outcomes evaluated, 23 outcomes were statistically significant.

For more information: lilly.com

Efgartigimod Alfa and Hyaluronidase-qvfc (Vyvgart Hytrulo)

Manufactured by: argenx BV

The FDA has approved efgartigimod alfa and hyaluronidase-qvfc to treat individuals with chronic inflammatory demyelinating polyneuropathy (CIDP). The drug is a once-weekly 30- to 90-second subcutaneous injection and is the first and only neonatal Fc receptor (FcRn) blocker to be approved for CIDP. The drug binds to the neonatal FcRn, which results in the reduction of circulating immunoglobulin G (IgG). The approval was based on results from the phase 2 ADHERE study (NCT04281472) that showed clinical improvement based on the Inflammatory Neuropathy Cause and Treatment disability score, indicating that IgG autoantibodies play an essential role in the biology of CIDP. Additionally, individuals treated with Vyvgart Hytrulo demonstrated a clinical benefit across all patient subgroups regardless of prior therapies. The safety profile was also consistent with that of previous clinical trials and the known safety profile of the drug.

For more information: us.argenx.com

OTC Product

Manufactured by: Natrol

Natrol has released Time Release Melatonin gummies, a sleep supplement intended to provide better sleep with minimal waking up during the night. The gummies are made with clean ingredients and contain no artificial flavors, artificial sweeteners, or synthetic dyes. The product is available in 3-mg and 10-mg doses with an extended-release mechanism. The company announced that the gummies are designed to empower individuals to manage their sleep health and wake up rejuvenated.

For more information: natrol.com

Generic Product

Posaconazole Delayed-Release Tablets

Manufactured by: Eugia Pharma Specialties Limited

The FDA has cleared posaconazole delayed-release tablets for the prophylaxis of invasive aspergillus and Candida infections in patients at high risk of developing infections as a result of immunocompromise, such as recipients of hematopoietic stem cell transplants with graft-vs-host disease or those with hematologic malignancies and prolonged neutropenia due to chemotherapy. Posaconazole, manufactured by Eugia Pharma Specialties Limited, a subsidiary company of Aurobindo Pharma Limited, is in a class of medications called azole antifungals, which work by slowing the growth of infection-causing fungi. Adverse effects can include fever, headache, chills or shaking, dizziness, weakness, gastrointestinal upset, and others.

For more information: aurobindo.com