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Clinical Insights: December 22, 2021

Posted on December 22, 2021 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug Approval

Apretude™ (cabotegravir) Extended-Release Injectable Suspension – New Drug Approval – December 20, 2021 – The U.S. Food and Drug Administration approved Apretude™ (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude™ is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude™ or take oral cabotegravir (Vocabria™) for four weeks to assess how well they tolerate the drug. <Read More> 

Vyvgart™ (efgartigimod alfa-fcab) Injection – New Drug Approval – December 17, 2021 – The U.S. Food and Drug Administration approved Vyvgart™ (efgartigimod) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody…Vyvgart™ is the first approval of a new class of medication. It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood. The medication causes a reduction in overall levels of IgG, including the abnormal AChR antibodies that are present in myasthenia gravis. <Read More>

Tezspire™ (tezepelumab-ekko) Injection – New Drug Approval – December 17, 2021 – FDA has approved Tezspire™ (tezepelumab-ekko) injection as an add-on maintenance treatment used to improve severe asthma symptoms when used with a patient’s current asthma medicine. Tezspire™ is approved for adults and children aged 12 years and older with severe asthma not controlled by their current asthma medicine. Tezspire™ is the first asthma treatment targeting thymic stromal lymphopoietin, a molecule involved in airway inflammation. Tezspire™ is also the first treatment for severe asthma that is not limited to a specific type of severe asthma. Tezspire™ is administered once every four weeks by a health care professional through a subcutaneous (under the skin) injection. <Read More>

Tarpeyo™ (budesonide) Capsules – New Drug Approval – December 17, 2021 – FDA has granted accelerated approval for Tarpeyo™ (budesonide) delayed release capsules to reduce proteinuria (increased protein levels in the urine) in adults with primary immunoglobulin A (IgA) nephropathy at risk of rapid disease progression. It has not been established whether Tarpeyo™ slows kidney function decline in patients with IgA nephropathy. IgA nephropathy, also known as Berger’s disease, is a rare kidney disease that occurs when IgA (a type of antibody) deposits build up in the kidneys, causing inflammation that damages kidney tissues. <Read More> 

Dartisla™ ODT (glycopyrrolate) Orally Disintegrating Tablets – New Drug Approval – December 17, 2021 – Edenbridge Pharmaceuticals, LLC announced that it has received approval from the U.S. Food and Drug Administration on its 505(b)(2) New Drug Application (NDA) for Dartisla™ ODT (glycopyrrolate) orally disintegrating tablets. Dartisla™ ODT is available in a 1.7 mg orally disintegrating tablet and is indicated for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Edenbridge will launch this product to the market in early 2022 as its first branded specialty prescription product. <Read More>

Entadfi™ (finasteride and tadalafil) Capsules – New Drug Approval – December 9, 2021 – Veru Inc., an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, announced that the U.S. Food and Drug Administration (FDA) has approved Entadfi™ for the treatment of urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia (BPH). <Read More>

New Indication/Dosage/Formulation Approval

Oxbryta® (voxelotor) Tablets – New Expanded Indication – December 17, 2021 – Global Blood Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of a supplemental New Drug Application (sNDA) for Oxbryta® (voxelotor) tablets for the treatment of sickle cell disease (SCD) in children ages 4 to less than 12 years. This approval expands the previously approved use of Oxbryta® to treat SCD in patients ages 12 years and older in the United States. The FDA also approved GBT’s separate New Drug Application (NDA) for Oxbryta® (voxelotor) tablets for oral suspension, a new dispersible, once-daily tablet dosage form suitable for patients ages 4 to less than 12 years as well as for older patients who have difficulty swallowing whole tablets. Oxbryta® is the first and only approved medicine that directly targets sickle hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD. <Read More>   

Xeljanz® (tofacitinib) Tablets and Oral Solution – New Approved Indication – December 14, 2021 – Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Xeljanz® / Xeljanz® XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. “We are proud to offer Xeljanz®, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease,” said Mike Gladstone, Global President, Inflammation & Immunology, Pfizer. “This regulatory approval affirms the clinical value and versatility of Xeljanz®, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions.” <Read More>

Rinvoq® (upadacitinib) Extended-Release Tablets – New Approved Indication – December 14, 2021 – AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib; 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. “The efficacy of Rinvoq® in relieving the many manifestations of psoriatic arthritis is well-characterized in two large, long term clinical studies,” said Michael Severino, M.D., vice chairman and president, AbbVie. “This new approval underscores our mission to deliver a portfolio of therapies that can help more people with rheumatic diseases achieve disease control.” <Read More>

New/Updated Drug Shortage

December 20, 2021

December 17, 2021

December 16, 2021

December 15, 2021

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Top-Tier Results Elusive Without Benchmarking – December 17, 2021 – Pharmacy departments contribute to the financial and clinical success of their health systems every day. But if your team isn’t documenting those outcomes and measuring performance with some type of benchmarking strategy, there may be a ceiling to those successes, experts noted during the 2021 ASHP Conference for Pharmacy Leaders, held virtually. <Read More>   

APhA: Pharmacist Burnout Hits Breaking Point, Impacting Patient Safety – December 17, 2021 – The Board of Trustees of the American Pharmacists Association issued the following statement:  We have heard loud concerns of overwhelmed pharmacists in busy pharmacies. We have also heard of potential pharmacist protests to their employers in the form of a sickout. Pharmacy workforce issues that lead to frustration and burnout are very real. They have been building for some time, but they have become more acute with the stressors brought on by the COVID-19 pandemic. Workplace conditions have pushed many pharmacists and pharmacy teams to the brink of despair. Pharmacy burnout is a significant patient safety issue. It is impacting patients today with delayed prescription fulfillment, unacceptable waits for vaccines and testing, and potential errors due to high volume, long hours and pressure to meet performance metrics. <Read More>

Pharmacy Organizations Update Oath of a Pharmacist – December 16, 2021 – The American Association of Colleges of Pharmacy (AACP) Board of Directors and the American Pharmacists Association (APhA) Board of Trustees have approved updates to the profession’s Oath of a Pharmacist to incorporate contemporary language and address diversity, equity, inclusion, and antiracism. The updates were recommended by a joint AACP and APhA Oath Revision Steering Committee and approved by the boards of AACP and APhA at their respective November 2021 meetings. “The joint committee led a critical charge of boldly expanding our professional oath to include the necessary elements of equity, inclusion, and diversity. The revised oath charges all pharmacists to take an active responsibility in promoting health equity and commit to being change agents in the system of pharmacy practice and beyond,” said Lakesha M. Butler, PharmD, CDFT, director of diversity, equity and inclusion at Southern Illinois University Edwardsville School of Pharmacy. <Read More>

Study: Data for Cross-Switching of Biosimilars Are Scarce but Supportive – December 16, 2021 – Investigators said more evidence would help to convince clinicians of the safety of switching between biosimilar products. Biosimilars are considered clinically equivalent to the biologic brand drugs they reference, but how about their equivalence, or lack thereof, to other biosimilars of the same brand drugs? A group of researchers set out to answer that question with an examination of the clinical trials literature on cross comparisons of biosimilars. They noted that the FDA generally is concerned only with whether the biosimilars it approves are equivalent to reference products but not whether biosimilars are equivalent to one another. That equivalence is implied, but the FDA does not issue approvals stating that expressly. <Read More>

CDC Endorses ACIP’s Updated COVID-19 Vaccine Recommendations – December 16, 2021 – The CDC is endorsing updated recommendations made by the Advisory Committee on Immunization Practices (ACIP) for the prevention of COVID-19, expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine over Johnson & Johnson’s COVID-19 vaccine. ACIP’s unanimous recommendation followed a robust discussion of the latest evidence on vaccine effectiveness, vaccine safety and rare adverse events, and consideration of the U.S. vaccine supply. The U.S. supply of mRNA vaccines is abundant – with nearly 100 million doses in the field for immediate use. This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom. Given the current state of the pandemic both here and around the world, the ACIP reaffirmed that receiving any vaccine is better than being unvaccinated. Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to Johnson & Johnson’s COVID-19 vaccine. <Read More>   

Planning for the New Year in Specialty Pharmacy: Tips to Help Patients Get Hassle-Free Refills – December 15, 2021 – Prescription drug coverage benefits can be confusing—and can often be a source of added stress for patients who manage chronic conditions or rare diseases. As specialty pharmacists, it’s our job to help patients have a smooth transition to a new benefit year so they don’t miss a dose of their life-changing or life-saving medication. Nearly half of all adults take steps to manage their prescription benefits before the new year, according to a survey AllianceRx Walgreens Prime conducted in 2018. To help ensure timely delivery of their prescriptions heading into the new year, pharmacists may need to remind patients to review their health plan information, schedule a doctor’s appointment, check on prior authorizations, or refill medications. <Read More>

Demand for COVID-19 shots, Staff Shortages are Fueling Pharmacist Burnout – December 15, 2021 – Pharmacies nationwide are struggling to meet demand for COVID-19 booster shots amid a shortage of pharmacists, Roll Call reported Dec. 15. About two-thirds of COVID-19 vaccines are administered in a pharmacy, according to estimates from the National Association of Chain Drug Stores. At the same time, about 70 percent of pharmacists are struggling to fill staff positions, a recent survey from the National Community Pharmacists Association found. Independent and retail pharmacies across the country are urging people to make appointments for vaccines, rather than coming during walk-in hours, to stay organized amid the intense workload. <Read More>

Many Paths to Specialty Success – December 15, 2021 – Summa Health, a hospital system in Akron, Ohio, chose to enter a partnership with Trellis Rx to launch its specialty pharmacy. The University of Illinois Chicago and University of Utah Health each built their own from scratch. Texas Children’s Hospital took a middle approach, using a consultant to help plan and launch, and ran it from there on its own. Regardless of the route, specialty pharmacy is an area many hospitals want to get into to improve the specialty medication experience for their patients and gain revenue they otherwise are outsourcing to commercial entities, said Ernest R. Anderson Jr., RPh, MS, a pharmacy consultant in Brockton, Mass. <Read More>

Walgreens in 2021: A Timeline of Key Events – December 14, 2021 – From expanding Village Medical at Walgreens locations to appointing leaders to forging partnerships, here is a timeline of key moves Walgreens made in 2021, as reported by Becker’s Hospital Review. Jan. 12: Walgreens Boots Alliance acquired the majority share of pharmacy automation technology company iA. March 4: Walgreens grew its digital health platform, Walgreens Find Care, by expanding four existing collaborations with healthcare providers and adding 11 new ones. March 15: Rosalind Brewer joined Walgreens Boots Alliance as CEO. April 12: Walgreens, Uber and PayPal partnered to launch a vaccine access fund to provide rides to COVID-19 vaccine appointments for Americans without reliable transportation. June 2: Walgreens Boots Alliance completed the sale of its wholesaling arm, Alliance Healthcare, to AmerisourceBergen for $6.5 billion… <Read More>

Targeting the Untargetable: Novel Agents in Acute Myeloid Leukemia – December 214, 2021 – Pharmacists have an important role in the optimization of AML therapies. Acute myeloid leukemia (AML) is the most common acute adult leukemia with an estimated 20,000 new cases annually in the United States and a median age at diagnosis of 68 to 71 years. With a complex pathophysiology, AML’s genetic mutations can cause accelerated growth and impaired differentiation in hematopoietic stem cells, leading to accumulation of immature myeloid cells. Over time, immature myeloid cells make up a progressively greater portion of the marrow, leading to impaired hematopoiesis and development of AML’s hallmark symptoms. <Read More>

Three Big Opportunities for Pharmacists in 2022 – December 14, 2021 – It may seem like folly to try to predict the future; however, if the COVID-19 era has taught us anything, it’s that things can rapidly change. But it’s always a good idea to be prepared for whatever may come next. If I had some kind of “Magic 8 ball” for pharmacists in 2022, here’s what it would say. 1) Prepare for the continuing expansion of scope to meet public health outcomes Nobody can argue that pharmacists are among the most trusted medical professionals. And with 90% of Americans living within 5 miles of a pharmacy, we are also some of the most accessible, supporting underserved and rural areas. That accessibility makes us key players in public health outcomes. COVID-19 changed our role in this arena, and in 2022, the trend should continue, with the expansion of clinical services to patient populations seeking more convenient and timely access to acute care services, such as birth control and tobacco cessation… <Read More>

Pharmacists Play Role in Preventing DUIDs – December 14, 2021 – Offering individual advice and counseling to patients can help combat the risks of driving under the influence of prescription drugs. Most of us know about the dangers of driving under the influence (DUI) of alcohol, which is also known as driving while intoxicated (DWI). In 2018 alone, the US alcohol-related impaired driving death toll reached an estimated 10,511 individuals, according to the CDC. But in addition to alcohol and illicit substances, medications commonly prescribed to patients can also impair driving. The National Highway Traffic Safety Administration (NHTSA) has started a campaign called “There’s More Than One Way to Be Under the Influence,” to enhance awareness about the effects that OTC and prescription medications can have on driving. <Read More>

FDA Issues Final Guidance on Pediatric Anti-Infective Development – December 13, 2021 – The US Food and Drug Administration (FDA) on issued a final guidance to assist sponsors in developing anti-infective drugs for the pediatric population. The guidance revises the draft version by providing more information on safety data collection and juvenile toxicity studies. The guidance provides recommendations for developing anti-infective drugs, including antibacterials, antifungals, and antiparasitic products, for pediatric populations. <Read More>

Top Pharmacy Innovations of 2021 – December 13, 2021 – From medication to legislation, multiple developments have advanced the pharmacy profession this year. The COVID-19 pandemic has brought many changes to the pharmacy profession. Because pharmacists are one of the most accessible health care professionals, they play an integral role in patient care management. From pediatric COVID-19 vaccines to the first interchangeable biosimilar products, multiple innovations have changed—and advanced—the pharmacy profession this year, and it is critical for pharmacists to stay up-to-date on these developments. <Read More>

Consumers are Holding Pharmacies and Manufacturers Accountable for Drug Safety – December 13, 2021 – Despite the strict oversight of pharmaceutical supply chains, they are far from perfect, and that’s severely affecting patients’ trust in both medications and the people producing, recommending and dispensing them. Seven in 10 patients who participated in Zebra’s Pharmaceutical Supply Chain Vision Study said they’re concerned about receiving stolen, contaminated, tainted, expired or counterfeit medicines. Many (43%) fear more illness and/or death could result without supply chain improvements. That probably explains why over 80% of patients expect manufacturers to detail how their medications are produced, handled, transported and stored. They want to be sure they aren’t going to be harmed by what they’re putting in their bodies to prevent and treat ailments. <Read More>

340B in the News

800+ Hospitals Urge HHS to Appeal Court Decision That Threatens 340B Pricing – December 20, 2021 – More than 800 hospitals participating in the 340B drug pricing discount program penned a letter to HHS Dec. 20, asking the federal government to appeal a Nov. 5 federal court decision that upheld price denials from two drugmakers. The letter says pharmaceutical manufacturers have been unilaterally denying 340B pricing to hospitals partnering with community-based pharmacies to dispense drugs. It references a decision from the U.S. District Court for the District of Columbia that upheld price denials by two manufacturers, though the decision did not declare their actions permissible under the 340B law. The ruling essentially allows drugmakers to “continue their unlawful denial of discounts that we rely on to serve our patients.” <Read More>

Five Changes Pharmacies Should Make in 2022, Per 2 Experts – December 15, 2021 – After a year of administering COVID-19 vaccines, battling medication shortages and experiencing a workforce shortage, hospital pharmacies will face a unique set of challenges and opportunities in 2022. Here, two hospital pharmacy executives share five changes they would like to see in the hospital pharmacy space in 2022. Responses were provided by Amir Emamifar, PharmD, chief pharmacy officer at Temple University Health System in Philadelphia, and Elie Bahou, PharmD, chief pharmacy officer at Providence in Renton, Wash. 1) Independent provider status for clinical pharmacy staff in each state. Dr. Emamifar said this effort will “support the long-standing role of pharmacists in public health.” He pointed out that clinical pharmacy staff play an important role in ensuring positive patient outcomes by improving medication management… <Read More>

Biden Releases 2,700-Item To-Do List: 5 Healthcare Updates – December 13, 2021 – President Joe Biden released a nearly 2,700-item regulatory to-do list Dec. 10 that targets mental healthcare, the 340B drug discount program and other healthcare issues through his administration’s rulemaking authority, according to Bloomberg Law…President Biden looks to initiate a dispute resolution panel to settle disputes between hospitals and drugmakers on issues regarding the 340B drug discount program. The effort has faced legal challenges, with a federal judge in March blocking HHS from implementing its administrative dispute resolution final rule. The new rule would replace the final rule and establish new requirements and procedures for the 340B program’s administrative dispute resolution process. <Read More>