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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 9
May 1, 2022

Chief Authors: Bonnie Broczkowski & Colleen Peehler
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Expands Approval of Veklury® to Treat Pediatric Patients®

On April 25, 2022, the U.S. Food and Drug Administration (FDA) approved Veklury® (remdesivir) to treat patients 28 days of age and older weighing at least 7 pounds who are hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are at high risk for progression to severe disease. Veklury® was previously approved to treat patients 12 years and older who weighed at least 88 pounds. The new approval was granted after evaluation of results from a  clinical study of 53 pediatric patients at least 28 days old weighing at least 7 pounds with laboratory confirmed mild, moderate, or severe COVID-19 disease. Patients in the trial received Veklury® for up to 10 days and the results showed that safety and effectiveness was similar to those seen in trials conducted in adults. Possible side effects of Veklury® include increased levels of liver enzymes and allergic reactions (changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, or shivering). Vaccination for eligible patients continues to remain the best practice for preventing and reducing the burden of COVID-19 disease. This approval now offers a treatment option for pediatric patients, some of whom may not currently have a vaccination option.

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Drug Safety

Abbott Recalls Powder Formulas Due to Risks of Bacterial Infection

On March 7, 2022, the FDA published Abbott Nutrition’s voluntary recall on one extra lot of Similac® powder formula in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were recalled in February. The recall was originally initiated due to complaints of bacterial infection in four infants who were ingesting formula made in one of Abbott’s manufacturing facilities and now expanded after there was a reported bacterial infection death of an infant who was also ingesting the formula. Routine testing found Cronobacter sakazakii, a type of bacteria, in an Abbott plant in Sturgis, Mich in a non-product contact area. This bacteria can cause rare but serious infections in infants such as dangerous blood infection called sepsis, spinal cord inflammation, or meningitis. Symptoms of infection may include temperature changes, poor feeding, excessive crying, low energy, jaundice, grunting breaths, abnormal body movements, rash or blood in the urine or stool. If patients experience any of the listed symptoms, they are to seek immediate care and report symptoms to the patient’s health care provider. Customers in possession of powder formulas should check the lots of the products and return the recalled products as instructed by the manufacturer. The FDA continues to investigate the case and so far, no bacteria were found in distributed products. The Centers for Disease Control and Prevention (CDC) advises patients to breastfeed when possible, clean and sanitize hands and feeding items, use liquid formula when possible, and safely store the powder formula to prevent Cronobacter sakazakii infection. 

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From the Pharmaceutical Industry

FDA Approves Epsolay® for the Treatment of Rosacea

On April 25, 2022, Sol-Gel Technologies and Galderma announced the FDA approval of Epsolay® (benzoyl peroxide, 5%) cream for the treatment of inflammatory lesions of rosacea in adults. Rosacea is a common skin condition that often begins with an increased tendency to blush or flush in the face and can eventually cause redness on the nose, cheeks, forehead and chin. Progression of the disease can cause acne-like breakouts, thickened and bumpy skin, visible blood vessels, and red and irritated eyes.  Epsolay® is a proprietary formula of benzoyl peroxide that encapsulates the drug within silica-based patented microcapsules that are designed to release benzoyl peroxide over time to optimize the cream’s safety and efficacy. The approval was granted after analysis of results from two clinical trials that compared Epsolay® to placebo in 733 patients with inflammatory lesions of rosacea. Epsolay® was more effective than placebo in both trials, reducing the number of inflammatory lesions by nearly 70% by the end of both trials, compared to a 38-46% with placebo. The most common adverse reactions to Epsolay® were application site reactions (pain, reddening, itchiness, and edema) each of which occurred in 2% or less of patients. 

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FDA Approvals

New FDA Approvals

Novel Drug Approval: Igalmi™ (dexmedetomidine)
Sublingual film approved for the treatment of agitation associated with schizophrenia or bipolar disorder in adult patients. [04/05/2022 – BIOXCEL THERAPEUTICS, INC.]

New Dosage Form:  Triumeq PD® (abacavir, dolutegravir, and lamivudine)
Oral tablets for suspension approved for the treatment of HIV in adult patients or pediatric patients who weigh at least 22 pounds. [03/30/2022 – Priority Review – VIIV HLTHCARE] 

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New Generics

New Generics Entering the Marketplace

BiDil® (isosorbide dinitrate/hydralazine)
Indication: Heart Failure
Dosage Form/Strength: 20 MG isosorbide dinitrate/37.5 MG hydralazine oral tablets
Average Wholesale Price (AWP): Generic = $366.42 | Brand = $426.46