Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 3 | Issue 20
October 15, 2021
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate
Clinical Pharmacy Update
CDC Confirms COVID-19 and Flu Vaccines Can Be Coadministered
Influenza viruses circulate annually in the United States from late fall to early spring. People who are infected with the influenza virus are at risk of serious illness, hospitalization, and even death, particularly in older adults, infants, pregnant women, and patients with a weakened immune system, but the flu vaccination provides significant protection from this illness. With the start of 2021-2022 influenza season and approval of the booster dose of COVID-19 vaccine, the recommended time for administration of seasonal influenza (flu) vaccines and COVID-19 vaccines may overlap for some patients. The Centers for Disease Control and Prevention (CDC) released recommendations regarding flu vaccines and stated that they may be coadministered with COVID-19 vaccines. This announcement varies from previous recommendations in which the CDC suggested that other vaccines should not be administered within 2 weeks before or after receiving COVID-19 vaccines. Although there is currently limited data on coadministration of the COVID-19 and flu vaccines, previous experiences with vaccine combinations show that the immune response and potential side effects are similar when vaccines are administered alone or coadministered with others. Receiving both flu and COVID-19 vaccines is essential for providing protection against both conditions in the general population.
Drug Safety
Eli Lilly Issues Nationwide Recall of Glucagon® Emergency Kit Due to Loss of Potency
On September 26, 2021, the FDA announced Eli Lilly and Company’s voluntary nationwide recall of one lot of Glucagon® Emergency Kit due to potential loss of potency. The emergency kit is indicated for severe low blood sugar, also known as hypoglycemia, in adults and children with diabetes and includes 1 mg of glucagon powder in a 3 ml vial and a 1 ml syringe of diluent. The recall was initiated after a product complaint indicating that the contents of the vial was received as liquid instead of powder. The company stated that this may have been related to issues with the manufacturing process but regardless the liquid may be ineffective in treating severe low blood sugar. If severe low blood sugar is not treated immediately in diabetic patients, potential complications could occur such as confusion, blurred vision, seizures, loss of consciousness or even death in extreme cases. The company is notifying its distributors and customers by written communication and has provided instructions for return and replacement of all recalled products. Individuals who experience any problems related to using this product should contact their physician or health care provider and adverse reactions or quality problems related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.
From the Pharmaceutical Industry
FDA Approves Qulipta™ (atogepant) For Preventative Treatment of Migraine in Adults
On September 28, 2021, AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Qulipta™ (atogepant) to prevent episodic migraine in adults. Episodic migraine is defined as having headaches with migraine symptoms between 0 to 14 days per month in contrast to chronic migraine, which is defined as having at least 15 headache days per month. Migraine is the most prevalent neurological disorder, affecting roughly 39 million people in the United States. Patients with migraines often suffer from recurring headaches with moderate to severe throbbing pain which is often accompanied by nausea, and/or sensitivity to light or sound. Qulipta™ is an oral calcitonin gene-related peptide (CGRP) receptor antagonist designed to prevent migraine. CGRP is a protein in the brain, that once attached to its corresponding receptor, may cause inflammation and transmit pain. A CGRP receptor antagonist blocks this mechanism, therefore helping prevent migraine attacks. The efficacy and safety of Qulipta™ was evaluated in a Phase 3 clinical study, ADVANCE, which included 2,270 participants with 4 to 14 migraine days who were randomly assigned to receive atogepant 10 mg, 30 mg, 60 mg or placebo for 12 weeks. The study evaluated the average changes in number of migraine days after the 12-week treatment. Results showed that the average changes were -3.7 days in patients who received atogepant 10 mg, -3.9 in patients who received atogepant 30 mg, -4.2 in patients who received atogepant 60 mg and -2.5 in patients who received placebo and also showed that all doses were well tolerated. Common side effects include nausea, constipation, fatigue and decreased appetite. With this approval, Qulipta™ offers the first and only CGRP receptor blocker specifically for prevention of episodic migraine with a convenient once daily oral dose.
FDA Approvals
New FDA Drug Approvals
Novel Drug Approval: Qulipta™ (atogepant)
Oral tablets approved for adult patients to prevent episodic migraine, which is defined as having headaches with migraine symptoms between 0 to 14 days per month. [09/28/21 – Priority Review – ABBVIE INC]
Novel Drug Approval: Livmarli™ (maralixibat chloride)
Oral solution approved for the treatment of cholestatic pruritus, intense itching associated with lack of bile flow in liver disease, in patients 1 year and older with Alagille syndrome (ALGS), a rare, genetic condition that affects multiple organs including the liver. [09/29/21 – Priority Review; Orphan Drug – MIRUM PHARMA INC]
New Generics
New Generic Medications Entering the Marketplace*
Fortaz® (ceftazidime)
Indication: Infections, including lower respiratory tract infections (LRTIs), skin infections and urinary tract infections (UTI).
Dosage Form/Strength: 1 and 2 GM Single-Dose Vials
Average Wholesale Price (AWP): Generic = $360 | Brand = $854