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Pulse Newsletter

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

Volume 4 | Issue 12
June 15, 2022

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

Clinical Pharmacy Update

FDA Authorizes Booster Dose in Children Ages 5 to 11

On May 17, 2022, the U.S. Food and Drug Administration (FDA) announced emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine as a single booster for children ages 5 to 11 who received their primary Pfizer-BioNTech COVID-19 Vaccine series at least 5 months prior. After evaluating the efficacy and safety data, the FDA concluded that the benefits of a single booster dose in children ages 5 to 11 outweigh the risks. The ongoing randomized placebo-controlled trial showed that the antibody response (a measure of how effective the vaccine is) was increased for the 67 participants who received a booster dose 7 to 9 months after completing a primary series of Pfizer-BioNTech COVID-19 Vaccine. The safety of Pfizer-BioNTech COVID-19 Vaccine as a single booster was evaluated in about 400 children, finding common side effects such as pain, redness and swelling at the injection site, fatigue, headache, muscle pain and fever, which is consistent with side effects reported from other age groups after administration of the vaccine. 

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Drug Safety

FDA Updates on Infant Formula

On May 16, 2022, the FDA issued guidance to import certain infant formula products and provide flexibilities to domestic manufacturers. The FDA aims to increase the supplies of infant formula responding to the shortage associated with Abbott Nutrition’s Similac®, Alimentum and EleCare product recall. Normally, 98% of infant formula consumed in the United States is produced domestically. The recent production and distribution issues have had a tremendous impact on the infant formula supply, as some infants rely on powder formula as their sole source of nutrition. Abbott has now resumed production with strict supervision from an independent expert to review the facility’s operations and ensure compliance with the law. On June 2, 2022, the FDA published an update on importing 249,500 cans of Nestlé infant formula from Nestlé, Germany. The following day, the FDA published another update on importing about 1.3 million cans of Gerber Good Start Gentle infant formula from Nestlé, Mexico. Additional deliveries of Nestlé formula are planned and will be announced once confirmed. The deliveries are expected to be available in store as early as this month. The FDA will review the nutritional adequacy and safety information of all imported products, has provided guidance regarding flexibility to manufacturers to further increase domestic production, and is working with other formula manufacturers to restore the supply of infant formula. 

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From the Pharmaceutical Industry

FDA Approves Novel Medication for Psoriasis

On May 24, 2022, Dermavant Sciences Inc. published FDA’s approval for Vtama® (tapinarof) 1% cream for the topical treatment of plaque psoriasis in adult patients. Plaque psoriasis is an autoimmune disease where the patients’ immune system attacks healthy cells and is characterized by raised red patches, accompanied by itching and pain. The approval of Vtama® makes it the first drug in a new class of medications that are used to treat plaque psoriasis. This unique agent, a topical aryl hydrocarbon receptor agonist, decreases the immune system’s reaction in the skin and damage-causing oxidative agents, causing the skin condition to stabilize. The efficacy and safety of Vtama® was evaluated in two randomized, double-blind trials with a total of 1,025 participants. Vtama® showed significant treatment success compared to the placebo group that used just the vehicle cream with no active medication. In the two trials, 36% and 40% of patients who received Vtama® once daily for 12 weeks achieved complete disease clearance compared to 6% in both placebo groups. Vtama® demonstrated a favorable safety and tolerability profile. Most common adverse reactions include red raised bumps around the hair pores, pain or swelling in the nose and throat, skin rash or irritation, headache, itching, and flu. Vtama® is expected to be available from the pharmacy by prescription in early June. 

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FDA Approvals

New FDA Approvals

Novel Drug Approval:  Vtama® (tapinarof)
Topical cream approved for treatment of plaque psoriasis in adults, a skin condition characterized by raised red patches accompanied by itching and pain. [05/23/2022 – DERMAVANT SCIENCES INC]

New Dosage Form:  Radicava ORS® (edaravone)
Oral suspension approved for the treatment of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), a rare disease that causes nerves to break down and results in progressive muscle weakness. [05/12/2022 – Orphan Drug; Priority Review – MITSUBISHI TANABE]

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New Generics

New Generics Entering the Marketplace

Vimpat® (lacosamide)
Indication: Seizure
Dosage Form/Strength: 10 MG/ML Solution
Average Wholesale Price (AWP): Generic = $132.33 | Brand = $294.15