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Pulse Newsletter

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

Volume 3 | Issue 18
September 15, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Pharmacy Update

Pfizer-BioNTech’s COVID-19 Vaccine Given Full FDA Approval

On August 23, 2021, the U.S. Food & Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s COVID-19 vaccine. The mRNA vaccine, now being marketed as Comirnaty®, is approved for use in individuals 16 years and older to prevent COVID-19 disease. The vaccine was initially approved under FDA emergency use authorization (EUA) in December 2020. The vaccine currently remains available under the previous EUA for individuals 12-15 years old and as an additional third dose in certain immunocompromised individuals. In order to grant Pfizer-BioNTech full approval, the FDA reviewed updated clinical trial data which included over 20,000 patients 16 years and older who received the vaccine and showed no evidence of COVID-19 infection within a week of receiving the second dose (allowing for the vaccine to have time to take effect). The vaccine was shown to be 91% effective in preventing COVID-19 when compared to placebo. The FDA also conducted an evaluation of safety surveillance data relating to myocarditis and pericarditis, both inflammatory heart conditions, following administration of the vaccine. It was determined that the vaccine posed an increased risk within 7 days following the second dose, with the risk being increased in men under age 40 and highest in males between the ages of 12 and 17. The FDA and CDC will continue post marketing studies to monitor and ensure that any safety concerns with the vaccine are being identified. 

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Drug Safety

Teligent Recalls Lidocaine Topical Solution 4% Due to Super Potency

On September 3, 2021, the FDA announced Teligent Pharma, Inc.’s voluntary recall of one lot of lidocaine HCl topical solution 4%, packaged in a 50ml glass bottle with a screw cap. This pain numbing treatment, often used in the mouth, nose and throat, was found to have a higher than indicated concentration, also known as super potency. Use of super potent lidocaine may result in higher than intended dose, which could lead to local anesthetic systemic toxicity (LAST) depending on how long the patient has used the treatment. LAST is a life-threatening adverse event that may result in central nervous system excitation/depression and serious cardiovascular problems, such as slower than normal heart rate, low blood pressure and even rapid cardiovascular collapse. If not recognized immediately and treated in a timely manner, LAST could result in severe adverse events and even death. Teligent has not received any reports of any adverse events at the time of the recall. The company is notifying its customers that the lot has been recalled and provided instructions for returning all recalled products. All consumers and patients who have the product should discontinue use and dispose of the product immediately. Individuals who experience any problems related to using this product should contact their physician or health care provider. In addition, adverse reactions or quality problems related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Oral Drug for Eczema Demonstrated Efficacy and Safety in Clinical Trial

On August 18, 2021, a randomized, phase 3 clinical trial, JADE TEEN, was published on JAMA Dermatology demonstrating the efficacy and safety of once-daily oral abrocitinib in combination with topical therapy for the treatment of moderate-to-severe atopic dermatitis (AD), also known as eczema, in adolescents. AD is a common chronic condition affecting both children and adults characterized by red, itchy and painful skin, which may have a significant impact on quality of life. It often begins in childhood and may persist into adolescence and adulthood. Conventional therapies for moderate-to-severe atopic dermatitis include avoiding known triggers, applying topical steroids to reduce inflammation, and moisturizing the skin to improve skin health. If a patient fails conventional therapies, an injectable drug known as Dupixent® may be considered for use in addition to topical steroids. In the JADE TEEN trial, 287 adolescent participants 12-17 years old with moderate-to-severe AD and weighing at least 121 pounds were randomly divided in three groups. The participants received a combination of topical therapy and either 200 mg abrocitinib, 100 mg abrocitinib or placebo for 12 weeks. The outcomes of the study were measured using an assessment tool known as the Investigator’s Global Assessment (IGA), which assesses the severity of AD on a scale of 0-4 with 0 being clear and 4 being severe, as well as the Eczema Area and Severity Index (EASI). Results from the trial showed that 46.2% of participants who received 200 mg abrocitinib and 41.6% in the 100 mg abrocitinib group achieved a score of 0 (clear) to 1 (almost clear) on the IGA, compared to 24.5% in the placebo group. Results from the EASI assessment showed 72% of the abrocitinib 200 mg and 68.5% of the abrocitinib 100 mg group experienced a 75% reduction in disease severity from baseline, compared to 41.5% in the placebo group. While adverse reactions occurred more frequently in the treatment groups compared to the placebo participants, serious adverse events occurred in 1.1% of the abrocitinib 200 mg group, 0% of the abrocitinib 100 mg group, and 2.1% of the placebo group. These results demonstrated that abrocitinib has the potential to be an effective and safe oral treatment for adolescent patients with atopic dermatitis in combination with topical therapy.

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FDA Approvals

New FDA Drug Approvals

Novel Drug Approval: Korsuva™ (difelikefalin acetate)
Intravenous infusion approved for the treatment of adult patients with moderate-to-severe itchy skin associated with chronic kidney disease (CKD-aP) whose kidneys require a dialysis machine to filter blood. [08/23/21 – Priority Review – Cara Therapeutics Inc]

Novel Drug Approval: Loreev XR----™ (lorazepam)
Extended-release capsules approved for the treatment of anxiety disorders in adults currently on a stable regimen of immediate release lorazepam for anxiety. [08/27/21 – Almatica Pharma, LLC]

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New Generics

New Generic Medications Entering the Marketplace*

Sutent® (sunitinib malate)
Indication: Gastrointestinal Stromal Tumor (GIST), tumors which form within the digestive tract; advanced kidney cell cancer; adjuvant treatment for patients with high risk of recurrent kidney cell cancer following kidney removal; pancreatic neuroendocrine tumors (pNET), tumors which form in the pancreas.
Dosage Form/Strength: 12.5, 25, 37.5, 50 MG Capsules
Average Wholesale Price (AWP): Generic = $22,798  | Brand = $25,331