Rx Product News- June 2023

Pharmacy TimesJune 2023
Volume 89
Issue 6

The FDA approved a molecular test for emergency use and a supplemental new drug application for a blood sugar medication.

Cue Mpox Molecular Test

From: Cue Health

The FDA has issued an emergency use authorization for a molecular test manufactured by Cue Health that detects the monkeypox (mpox) virus. The Cue Mpox Molecular Test demonstrated high accuracy in clinical trials, with a 100% concordance with the CDC’s mpox test on the samples tested. It is a nucleic acid amplification test, which can be performed at any clinical laboratory improvement amendments–waived facility. The test is designed to deliver results in 25 minutes, expanding access to accurate and fast testing for the disease. A Cue Sample Wand should be used to collect a lesion sample or dip into a viral transport medium that contains a specimen, and then the wand is inserted into the Cue Cartridge with the Cue Reader. The results are delivered to a mobile device.

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Empagliflozin (Jardiance)

From: Boehringer Ingelheim; Eli Lilly and Company

The FDA has accepted a supplemental new drug application (sNDA) for empagliflozin (Jardiance; Boehringer Ingelheim, Eli Lilly and Company) for a potential new indication, treating lower blood sugar, with diet and exercise, in children aged 10 to 17 years with type 2 diabetes. The sNDA is based on results from the DINAMO phase 3 trial (NCT03429543), showing that empagliflozin was associated with a statistically significant reduction in the primary end point of change from baseline in hemoglobin A1c (HbA1c) levels at 26 weeks compared with placebo. Investigators also found that when added to other baseline treatments, including diet, exercise, insulin, and/or metformin, empagliflozin reduced HbA1c levels by 0.84% compared with placebo at week 26. The safety profile was also consistent with the previously known safety profile of empagliflozin.

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Zavegepant (Zavzpret)

From: Pfizer Inc

The FDA has approved zavegepant (Zavzpret; Pfizer Inc) as the first calcitonin gene-related peptide receptor antagonist nasal spray for the acute treatment of migraines in adults with or without aura following clinical trial results showing that the drug is effective, safe, and tolerable. The drug was found to be statistically superior to the placebo. The nasal spray met the coprimary end points of reduced moderate to severe headache pain to no pain, and self-identified reduction in the most bothersome symptoms 2 hours after treatment. The most common adverse events included ageusia, dysgeusia, nasal discomfort, nausea, and vomiting.

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Ivacaftor (Kalydeco)

From: Vertex Pharmaceuticals Incorporated

The FDA has approved ivacaftor (Kalydeco; Vertex Pharmaceuticals Incorporated) for children aged 1 month to 4 years with cystic fibrosis (CF) and a mutation in their CFTR gene. It is the first CFTR modulator that is approved for infants as young as 1 month. The FDA approval is based on clinical trial results that evaluated pharmacodynamics, pharmacokinetics, and treatment safety in a population of infants aged 4 to 6 months who have mutated CF. CF is a multi-organ, progressive disease caused by a defective or missing CFTR protein. It can affect major organs, specifically the lungs, where thick mucus builds up, and can lead to chronic lung infections and organ damage. Ivacaftor is designed to transport salt and water across cell membranes to clear mucus from the airways. Ivacaftor first received US approval in 2012.

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