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Pulse Newsletter

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

Volume 3 | Issue 24
December 15, 2021

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

Clinical Pharmacy Update

FDA, CDC and COVID-19 Vaccine Pharma Companies Respond to Omicron Variant

On November 26, 2021, the Centers for Disease Control and Prevention (CDC) released a statement on the COVID-19 Omicron variant indicating they are working closely with the South African government and global scientific community in response to the new variant. CDC recommends people continue following preventative measures such as wearing masks, washing hands frequently, getting fully vaccinated and encourages eligible people to receive a COVID-19 booster dose. On November 30, 2021, the U.S. Food and Drug Administration (FDA) also released a statement on Omicron variant indicating they have been actively monitoring for the COVID-19 variants including Omicron and have asked companies to closely monitor the effectiveness of their products in relation to the variant as it emerges in the U.S. The FDA believes that the efficacy of PCR and antigen tests are unlikely to be affected by the new variant and expects cases of Omicron variant to be rapidly identified and monitored. Moderna, Pfizer-BioNTech and Johnson & Johnson (J&J) are all taking measures in response to the new Omicron variant. On November 26, Moderna published a detailed, three-component strategy to address the variant which includes beginning a clinical study with 306 participants to test on a higher dose of the vaccine, studying two multi-valent booster vaccines that were designed to anticipate mutations like those in Omicron variant, and working towards the development of an Omicron specific booster which Moderna hopes to launch in three to six months. On December 6, the most recent Pfizer-BioNTech news release stated that the company is expecting to adapt a new Omicron-specific vaccine in March 2022. The company has conducted preliminary laboratory studies that confirmed reduced effectiveness against Omicron variant after the initial two dose series, but a booster dose has been shown to improve the response by 25-fold. J&J has been working with associates in South Africa and around the world to evaluate the effectiveness of its vaccine. They are also working on designing a new vaccine and will proceed to clinical trial if necessary. 

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Drug Safety

Nationwide Recall of Enoxaparin Due to Exposure to High Temperature

On December 01, 2021, Sandoz, Inc. announced a nationwide recall of one lot of enoxaparin sodium injection due to temperature excursion during shipping in the months of September and October 2021. Enoxaparin is an anticoagulant (blood thinner) medication used to prevent or treat deep vein thrombosis (DVT), a condition when a blood clot forms in a deep vein. Exposure to high temperature may significantly impact the effectiveness of the medication putting patients at greater risk of blood clots and may lead to pain, swelling, stoke, clots travelling to the lung or even death. To date, no reports of product complaints or adverse events associated with the recall have been made to Sandoz. The company is notifying its wholesalers and retailers about the recall and has made arrangements for return of all affected product. Patients should discontinue use immediately, contact their prescriber for a new prescription and follow through with return arrangements of the recalled product. Patients experiencing any adverse events related to the recall are advised to contact their physician or health care provider and adverse reactions or quality problems relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

FDA Panel Recommends Approval of Merck’s COVID-19 Pill

On November 30, 2021, the FDA’s advisory panel voted to recommend the emergency use authorization of Merck’s antiviral medication molnupiravir. If approved, this would be the first oral agent available for the treatment of patients with mild to moderate COVID-19. Molnupiravir works by incorporating itself into the SARS-CoV-2 viral RNA to inhibit replication of the virus. After evaluating safety and efficacy data provided by Merck, the FDA panel voted 13-10 to approve the use of molnupiravir under emergency use authorization. The drug was studied in a Phase 3 trial which enrolled non-hospitalized patients 18 years and older, within 5 days of symptom onset of mild to moderate COVID-19 disease, who were at high risk for severe illness. Patients receiving molnupiravir were given either 200, 400, or 800 mg or placebo orally every 12 hours for 5 days. The primary endpoint of the study, percentage of participants with all cause hospitalization or death through day 29, was found to be 7.3% in the molnupiravir group and 14.1% in the placebo group. Molnupiravir was overall well tolerated with an acceptable safety profile. Treatment with molnupiravir should be started within 5 days of symptom onset. Although molnupiravir was primarily studied in patients who were infected with the Delta, Mu, and Gamma variants of COVID-19, there is belief that because of its mechanism of action, it would provide a similar benefit against the Omicron variant. Molnupiravir is not meant to be an alternative to vaccination, but simply provides another treatment option to reduce the risk of hospitalization or death in those who are infected by COVID-19. 

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FDA Approvals

New FDA Drug Approvals

Novel Drug Approval: Livtencity™ (everolimus)
Oral tablets approved for the treatment cytomegalovirus (CMV), a common type of virus, infection in patients 12 years and older weighing at least 77 pounds who have received an organ transplant and have been previously treated with, but did not respond to, first-line antiviral medications. [11/23/21 – Priority Review; Orphan Drug – TAKEDA PHARMS USA]

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New Generics

New Generic Medications Entering the Marketplace

Zortress® (everolimus)
Indication: Prevention of organ rejection in kidney or liver transplantation
Dosage Form/Strength: 1MG Tablets
Average Wholesale Price (AWP): Generic = $1,268.57 | Brand = $1,335.34