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Pulse Newsletter

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

Volume 3 | Issue 14
July 15, 2021

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

Clinical Pharmacy Update

FDA Approves First Oral Blood Thinner for Use in Children

On June, 21, 2021, the U.S. Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate) oral pellets for the treatment and prevention of recurrent venous thromboembolism (VTE) in children 3 months to less than 12 years who have been treated with an injectable blood thinner for at least five days. VTE is a rare but severe disease where blood clots form in the veins. The standard of care for VTE includes injectable blood thinners, which may require close laboratory monitoring and dose adjustment. In 2010, Pradaxa® was originally approved to reduce the risk of stroke and blood clots in adults with a heart condition known as atrial fibrillation. This new formulation of Pradaxa® is the first FDA-approved oral blood thinner for children. Its safety and efficacy were evaluated in a study of 267 pediatric patients who were randomly assigned to be treated with either Pradaxa® or the standard of care. Results showed that Pradaxa® had similar efficacy and safety when compared to standard of care, with 45.8% of the Pradaxa® group meeting the clinical endpoints of the trial (lack of mortality due to a blood clot, resolution of the clot, and lack of formation of new clots during treatment), compared to 42.2% of the standard of care group. The safety of Pradaxa® when used for prevention of VTE was evaluated in another study of 214 pediatric patients with a history of blood clots and found to be comparable to prior standards of care with only 1.4% of patients experiencing a recurrent clot. This new dosage form presents pediatric patients with an alternative option to treat and prevent potentially life-threatening blood clots, especially those at higher risk, such as children with cancer, congenital heart disease or those admitted for intensive care.

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Drug Safety

Pfizer Halts Distribution of Smoking-Cessation Drug

On June 24, 2021, Pfizer announced a pause of worldwide distribution of its smoking-cessation product, Chantix® (varenicline), due to elevated levels of a nitrosamines found in certain lots of the drug. Nitrosamines are of a class of compounds which are known to be possible human carcinogens (substances known to cause cancer). In addition to the halt in distribution, nine lots of Chantix® have been voluntarily recalled by Pfizer at the warehouse level. The FDA posted a drug safety communication with information on the recall and has advised individuals using Chantix® to not change the way they are taking their medication without first consulting their health care provider. A recall at the consumer level has not been made and Pfizer noted that the increased cancer risk due to nitrosamines is associated with long-term exposure and therefore there is no immediate risk to individuals using Chantix®. Pfizer is expected to hold the release of all Chantix® products into the U.S. market until acceptable nitrosamine levels are confirmed. Questions regarding the recall can be made directly to Pfizer. Adverse reactions related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Moderna’s COVID-19 Vaccine Shows Promise Against New Virus Variants

On June 29, 2021, Moderna issued a press release providing an update on the efficacy of its mRNA based vaccine on new variants of the COVID-19 virus. The CDC is classifying these new variants as variants of interest or concern based on their association with, or evidence of them having attributes such as increased levels of transmissibility, ability to cause more severe disease or reduced efficacy of already existing treatments. Moderna is studying the response of its vaccine against these newly emerging variants and released their process of testing the vaccine against newly emerging strains of COVID-19 earlier this year. Blood samples from eight individuals who had received a complete two-dose series of the Moderna COVID-19 vaccine were first used to perform tests to detect whether antibodies are able to stop the spread of the virus against new strains that were identified in the United Kingdom and the Republic of South Africa. Now, Moderna has performed an additional analysis on several other variants that have emerged, including the delta variant that was first isolated in India. The most recent data shows that the vaccine has activity against multiple new variants of COVID-19 detected around the globe. While it has been found that the level of response the vaccine produced against new variants was not as robust as it was against the original strain, Moderna believes the data is encouraging and says the vaccine should remain protective against newly detected variants. Moderna is also exploring the role of a multivalent booster, consisting of a 50-50 mix of the original vaccine in addition to genetic material encoding for the beta variant, with the goal of increasing the scope of response to variants.

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FDA Approvals

New FDA Drug Approvals

New Dosage Form: Pradaxa® (dabigatran etexilate)
Oral pellets approved to treat and prevent venous thromboembolic events (VTE) in pediatric patients 3 months to less than 12 years [06/21/21 – Priority Review – BOEHRINGER INGELHEIM]

New Formulation: Verkazia® (cyclosporine)
Ophthalmic emulsion approved for the treatment of adult and pediatric patients with vernal keratoconjunctivitis (VKC); a rare, chronic severe allergic condition that affect the surfaces of the eyes. [06/23/21 – Orphan Drug – SANTEN]

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New Generics

New Generic Medications Entering the Marketplace

Intelence® (etravirine)
Indication: Human immunodeficiency virus type 1 (HIV-1) infection
Dosage Form/Strength: 100 MG, 200 MG Oral tablet
Average Wholesale Price (AWP): Generic = $1,609 | Brand = $1,694