Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 3 | Issue 21
November 1, 2021
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate
Clinical Pharmacy Update
COVID-19 Treatment and Vaccine Booster Updates
Merck has called upon the U.S. Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) for its antiviral pill molnupiravir, intended for the treatment of mild-to-moderate COVID-19 in individuals at risk of severe disease or hospitalization. Merck claims that in trials the antiviral medication has shown to cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The FDA is expected to perform a thorough analysis of all available safety and efficacy data associated with the antiviral medication before granting any type of approval. Among the testing groups, side effects were similar for those that received active drug compared to the group that received placebo, but the detailed types of problems were not publicly reported. While vaccination remains the best practice for reducing the risk of complications of COVID-19, if approved, this self-administered oral pill would be the first EUA treatment for COVID-19 that does not require an IV or injection and would help alleviate the tremendous stress that is currently being placed on U.S. hospitals handling the coronavirus pandemic.
As of October 21, 2021, the FDA and Centers for Disease Control and Prevention (CDC) are now recommending a booster dose of the Moderna, Pfizer and J&J COVID-19 vaccines in certain populations. For those that received initial vaccination with Moderna or Pfizer at least 6 months ago, the booster dose is recommended for all 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. The COVID-19 booster vaccine is recommended for all individuals 18 years of age and older that received the J&J vaccine more than 2 months ago. The updated recommendations allow for patients to choose among the 3 vaccines available, without regard to the manufacturer received at the initial vaccination. Millions of eligible Americans may begin to receive booster shots, which will provide additional protection from COVID-19.
Drug Safety
Nationwide Recall of Blood Pressure Medication Due to Impurity
On October 14, 2021, the FDA announced Lupin Pharmaceuticals, Inc.’s voluntary recall of all irbesartan and irbesartan/hydrochlorothiazide combination tablets due to a potential contamination with the impurity N-nitrosoirbesartan, which is a probable cancer-causing substance based on laboratory tests. The voluntary recall was made at the consumer level out an abundance of caution after an analysis revealed that certain batches contained more than the specified limit of the impurity. Irbesartan and combination irbesartan/hydrochlorothiazide are both indicated to treat high blood pressure. From October 8, 2018, through September 30, 2021, Lupin received 4 reports of illness from irbesartan tablets and no reports of illness from the combination irbesartan/hydrochlorothiazide. Lupin Pharmaceuticals has notified its wholesalers and distributers about the recall and is arranging for return of all recalled products. Individuals taking irbesartan or irbesartan/hydrochlorothiazide are advised to continue taking their medication and to not discontinue treatment without consulting their pharmacist, physician, or medical provider. Adverse reactions or quality problems relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
From the Pharmaceutical Industry
FDA Approves the First Biosimilar to Humira®
On October 18, 2021, the FDA approved Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar product for Humira®. Biosimilars are products that are highly similar to and have no clinically meaningful differences from a reference product that has already been approved by the FDA. Biologics are among the fastest growing prescription drug types, making biosimilars and interchangeable biosimilar medications important in improving patient access to more treatment options and potentially less expensive alternatives. Interchangeable biosimilars meet additional requirements outlined by the FDA, and unlike standard biosimilars, may be automatically substituted for the reference product without additional approval from a physician. Cyltezo®, a single-dose, pre-filled syringe that is administered under the skin, was initially approved in August of 2017. Cyltezo® is interchangeable and may be automatically substituted for Humira® for all shared approved indications, including psoriatic arthritis, moderate to severe rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and juvenile idiopathic arthritis (JIA). Common side effects associated with the use of Cyltezo® include upper respiratory and sinus infections, injection site reactions, headache and rash. This approval is notably the second interchangeable biosimilar product approved by the FDA. To date, the FDA has approved 31 biosimilars, which are helping improve patient access to expensive treatments for a variety of serious and complex conditions.
FDA Approvals
New FDA Drug Approvals
Novel Drug Approval: Tavneos™ (avacopan)
Oral capsules approved for adult patients in combination with glucocorticoid therapy for severe active inflammation of small blood vessels associated with anti-neutrophil cytoplasmic autoantibody (ANCA), an autoimmune disease associated with the attack of healthy white blood cells, which in turn attack small blood vessels. [10/07/21 – Orphan Drug – CHEMOCENTRYX, INC]
New Dosage Form: Sertraline
Oral capsules approved for the treatment of major depressive disorder in adult patients, and obsessive-compulsive disorder (OCD) in patients 6 years and older. [10/04/21 – ALMATICA]
New Generics
New Generic Medications Entering the Marketplace
Afinitor® (everolimus)
Indication: Breast cancer, various types of neuroendocrine tumors (NET), advanced renal cell carcinoma (RCC), tuberous sclerosis complex (TSC), a genetic disorder known to cause tumors.
Dosage Form/Strength: 2, 3, 5 and 10 GM Tablets
Average Wholesale Price (AWP): Generic = $18,167 | Brand = $20,193