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Pulse Newsletter

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

Volume 4 | Issue 2
January 15, 2022

Chief Author: Dana Ranallo, PharmD
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Leqvio® as Adjunct Cholesterol Lowering Therapy

December 22, 2021, the U.S. Food and Drug Administration (FDA) approved Leqvio® (inclisiran) for additional low-density lipoprotein cholesterol (LDL-C) lowering in adult patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) currently being treated with maximally tolerated statin therapy. ASCVD is a group of diseases in which patients have a build-up of cholesterol plaque in their arteries and may lead to heart conditions such as sudden reduced blood flow to the heart, heart attack and stroke. HeFH, which affects approximately 1 in 250 people, is a life-threatening condition characterized by a mutation in the genes responsible for the natural lowering of cholesterol levels, often resulting in significantly higher levels of LDL-C. LDL-C, also referred to as “bad cholesterol”, is a type of protein that carries cholesterol throughout the body and high levels are associated with an increased risk for heart attack, stroke and coronary artery disease. Leqvio® is administered by a health care provider and is given as a 284 mg injection initial dose followed by a second dose three months later, and then every six months thereafter. Leqvio® works by interfering with genetic material in liver cells resulting in decreased levels of a protein called PCSK9. By blocking PCSK9, a patient’s liver can better regulate LDL-C levels, including an increased ability to remove LDL-C from the blood. The efficacy of Leqvio® was studied in three randomized clinical trials enrolling 3,457 adult patients with either HeFH or ASCVD who were currently receiving maximally tolerated statin therapy but had not achieved their targeted LDL-C level. In each trial, the participants were divided into two groups and given four doses of either placebo or 284 mg Leqvio® on day 1, 90, 270 and 450. The results of the three studies all showed positive results with the group receiving Leqvio® having a decreased LDL-C of 51%, 46%, and 40%, whereas the placebo groups had an increased LDL-C of 1%, 4%, and 8%, respectively. Common side effects of Leqvio® include injection site reaction, joint pain, urinary tract infection, diarrhea, pain in legs or arms and shortness of breath. This biannual injection provides a new treatment option for high-risk patients who are not at their recommended LDL-C target and is considered an adjunct therapy with a balanced diet and statin therapy. 

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Drug Safety

Nitroglycerin Lingual Spray Recalled Nationwide Due to Possible Dispensing Unit Malfunction

On December 27, 2021, the FDA announced Padagis US LLC’s voluntary recall of three lots of Nitroglycerin Lingual Spray. The recall was initiated out of caution due to a complaint received that a unit may not dispense the amount of medication as intended. Nitroglycerin Lingual Spray is indicated to acutely treat or to prevent chest pain in adult patients with coronary artery diseases. If a patient who is experiencing chest pain uses a Nitroglycerin Lingual Spray that does not dispense the intended amount of medication, the patient may not obtain relief and should seek medical attention if the chest pain lasts over 15 minutes. To date no reports of adverse events associated with the recall have been made to Padagis. The company is notifying its distributors and customers about the recall and has asked that they outreach to patients who may have obtained the recalled medication. Padagis has made arrangements for the return of all recalled products. Patients should contact their prescriber for an alternative replacement before discontinuing therapy and should follow through with return arrangements. Any patient experiencing adverse events related to the recall are advised to contact their physician or health care provider and adverse reactions or quality problems should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

First Biologics in Its Class, Adbry™, Approved for the Treatment of Atopic Dermatitis

On December 28, 2021, LEO Pharma Inc. announced the FDA’s approval for Adbry™ (tralokinumab) bi-monthly, under-the-skin injection for the treatment of moderate-to-severe atopic dermatitis, also known as eczema, in adult patients who are not well controlled with topical steroids or whose disease is not suitable for topical therapy. Atopic dermatitis is an inflammatory skin condition characterized by intense itch, rash, and skin dryness which can be unpredictable and difficult to treat. Topical steroids remain the first-line therapy for atopic dermatitis and may continue to be used in addition to treatment with Adbry™ in some instances. Other treatment options include topical calcineurin inhibitors (medications that works to suppress the immune system) and injectable treatments such as Dupixent®. Dupixent® works to treat atopic dermatitis by targeting and inhibiting two inflammatory mechanisms, IL-4 and IL-13, whereas Adbry™ specifically targets inflammatory mechanism IL-13 and is the first medication to do so. The efficacy of Adbry™ was studied in three randomized clinical trials including nearly 2,000 adult participants with moderate-to-severe atopic dermatitis, and results were assessed using an overall evaluation of number and severity of skin lesions and percentage of body surface area affected by the disease. The participants were divided into two groups, each of which received one 600 mg injection of Adbry™ or placebo followed by either placebo or a 300 mg of injection of Adbry™ every other week. Responders were identified as those whose lesions were characterized as clear or almost clear and those who had a greater than 75% improvement in affected area and severity of eczema. In all three trials the Adbry™ group had significant improvement of atopic dermatitis symptoms compared to placebo as well as a higher proportion of individuals achieving 90% improvement.  The most frequent adverse events noted in the trials included upper respiratory tract infections, pink eye, injection site reactions and high white blood cell levels. Adbry™ is expected to be available in the U.S. by February 2022.

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FDA Approvals

New FDA Approvals

Novel Active IngredientRecorlev® (levoketoconazole)
Oral tablets approved for the treatment of long-term high cortisol exposure in adult patients who are not eligible for or have not experienced success with pituitary surgery. [12/30/2021 – Orphan Drug – STRONGBRIDGE DUBLIN LTD]

New Dosage Form: Xarelto® (rivaroxaban)
Oral suspension approved for the treatment and prevention of pulmonary embolism (a blood clot in the lungs) and/or deep vein thrombosis (a blood clot in the legs) in adult patients. [12/20/2021 – Priority Review – JANSSEN PHARMS]

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New Generics

New Generics Entering the Marketplace

Cuvposa® (glycopyrrolate)
Indication: Reduce chronic severe drooling in patients ages 3-16 years
Dosage Form/Strength: 1MG/5ML Oral Solution
Average Wholesale Price (AWP): Generic = $34.21 | Brand = $38.02