Your source for the latest industry trends and drug information news.
Volume 3 | Issue 23
December 1, 2021
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate
On November 19, 2021, the U.S. Food and Drug Administration (FDA) updated its emergency use authorizations (EUA) for COVID-19 vaccines, expanding those eligible to receive a booster dose. Both the FDA and the Centers for Disease Control and Prevention (CDC) now recommend that all individuals 18 years and older who have been vaccinated against COVID-19 receive a booster dose, without regard to the manufacturer of the initial vaccination. Prior to this update, the booster dose was only recommended for individuals over the age of 65, and for those between ages 18-64 at high risk of severe COVID-19 or at high risk for infection due to institutional or occupational exposure. Individuals who received the Moderna or Pfizer-BioNTech can receive a booster dose as early as 6 months after the initial series, while those who received the Johnson & Johnson vaccine can receive a booster dose as early as 2 months after the initial dose. The booster for the Pfizer-BioNTech and J&J vaccines is given at the same dose, while the Moderna vaccine is administered at half the dose of the initial series. The FDA EUA updates were made after analysis of data from clinical studies showed that individuals who received a booster dose demonstrated an increased immune response in the form of antibody production. Safety of a booster dose was also demonstrated through analysis of real-world-data, which showed that the benefits of a single booster dose of either vaccine outweighed any risk of side effects in individuals 18 years and older. Commonly reported side effects following administration of a booster dose were consistent with those reported after the initial vaccination series, and included pain, redness, and swelling at the injection site, as well as fatigue, chills, headache and muscle and/or joint pain. The FDA and CDC will continue to monitor the risk and incidence of serious side effects like myocarditis and pericarditis through post-marketing studies.
On November 19, 2021, Sagent Pharmaceuticals, Inc. announced a voluntary nationwide recall of four lots of levetiracetam injection due to a potential sterility issue. Levetiracetam is an anticonvulsant medication used to treat certain types of seizures and is provided in various formulations, including oral tablet, solution and intravenous injection. The recall was made after a lack of container closure reliability was found in reserve sample vials of a preparation that is intended to be administered intravenously. Intravenous administration of a non-sterile product can result in serious, life-threatening infections. Due to this finding, Sagent has recalled four lots of its 5 mL single-dose vials that were distributed between March and November of 2021. The company is also notifying customers about the recall and has made arrangements for return of all affected product. Distributors have been advised to contact any patients who may have received affected lots, to immediately discontinue use and follow through with return arrangements. Patients experiencing any adverse events related to the recall are advised to contact their physician or health care provider. To date, no reports of product complaints or adverse events associated with the recall have been made to Sagent. Adverse reactions or quality problems relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
On November 12, 2021, the FDA approved Besremi® (ropeginterferon alfa-2b-njft) injection for the treatment of adults with polycythemia vera, a rare blood disease that affects approximately 6,200 patients each year in the United States. Individuals with polycythemia vera have a mutation that causes the bone marrow to overproduce red blood cells. This increased number of circulating red blood cells causes a “thickening” of blood which impairs the ability of blood to freely flow through blood vessels. This slowed blood flow can cause a variety of symptoms including headache, fatigue, weakness, itchy skin and enlargement of the spleen. Polycythemia vera may also put patients at increased risk of blood clots and related complications such as heart attack and stroke. Common treatments for polycythemia vera include medications as well as procedures that work to reduce the number of circulating red blood cells in the body. Basemri®, an injectable drug administered every two weeks, is a new treatment option for patients that is thought to work by inhibiting the ability of bone marrow to produce red blood cells. The efficacy and safety of Basemri® was evaluated in a clinical trial which showed that 61% patients receiving Basemri® achieved a “complete hematological response,” maintaining normal levels of red and white blood cells and platelets. Once a patient has been stable on Basemri® for at least one year, they may reduce the frequency of administration to once every four weeks. Basemri® may cause side effects such as elevations in liver enzymes, reductions in white blood cells and platelets, joint pain, fatigue, itching, upper airway infection, and muscle pain, flu-like symptoms, and in some cases transient ischemic attacks (stroke-like attacks). Medications categorized as interferon products (manmade proteins that mimic those naturally produced by the body) such as Basemri® have the potential to worsen certain neurologic and autoimmune conditions, which can lead to life-threatening complications. With this, patients should be thoroughly evaluated by a rare disease specialist to determine if they are a candidate for Basemri®.
Novel Drug Approval: Voxzogo™ (vosoritide)
Injection approved to increase linear bone growth for children 5 years and older diagnosed with achondroplasia, a form of short-limbed dwarfism caused by a specific genetic mutation 11/19/21 – Priority Review; Orphan Drug – BIOMARIN PHARM]
Antara® (fenofibrate)
Indication: To reduce blood cholesterol and triglycerides
Dosage Form/Strength: 30 and 90 MG Capsules
Average Wholesale Price (AWP): Generic = $548.57 | Brand = $609.53
