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Clinical Insights: March 20, 2024

Posted on March 20, 2024 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/Vaccine Approval

Lenmeldy™ (atidarsagene autotemcel) – New Drug Approval – March 18, 2024 – Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, announced the U.S. Food and Drug Administration (FDA) has approved Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ)—collectively referred to as early-onset—metachromatic leukodystrophy (MLD). <Read More>

Rezdiffra™ (resmetirom) Tablets – New Drug Approval – March 14, 2024 – The U.S. Food and Drug Administration approved Rezdiffra™  (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise…NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction. NASH is often associated with other health problems such as high blood pressure and type 2 diabetes. <Read More>

Tevimbra® (tislelizumab-jsgr) Injection – New Drug Approval – March 13, 2024 – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra® will be available in the U.S. in the second half of 2024. <Read More>

New Indication/Dosage/Formulation Approval

Xhance® (fluticasone propionate) Nasal Spray – New Label Expansion – March 15, 2024 – Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, announced the U.S. Food and Drug Administration (FDA) has approved Xhance® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. <Read More>

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion – New Label Expansion – March 14, 2024 – Bristol Myers Squibb (NYSE: BMY) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). <Read More>

Livmarli® (maralixibat) Oral Solution – New Label Expansion – March 13, 2024 – Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) announced that the U.S. Food and Drug Administration (FDA) has approved Livmarli® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC). Mirum has also submitted an additional supplemental new drug application (sNDA) to introduce a higher concentration formulation of Livmarli®, used during the MARCH study, to enable label expansion for younger patients with PFIC, later this year. Livmarli® is also approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. (three months and older), Europe (two months and older), in Canada and other regions globally. <Read More>

Praluent® (alirocumab) Injection – New Label Expansion – March 8, 2024 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). <Read More>

Wegovy® (semaglutide) Injection -New Label Expansion – March 8, 2024 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease (CVD). <Read More>

Brukinsa (zanubrutinib) Capsules – New Label Expansion – March 7, 2024 – The Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa®, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The regimen was evaluated in Study BGB-3111-212 (ROSEWOOD; NCT03332017), an open-label, multicenter, randomized trial that enrolled 217 adult patients with relapsed or refractory FL after at least 2 prior systemic treatments. <Read More>

Opdivo® (nivolumab) Injection – New Label Expansion – March 6, 2024 – The Food and Drug Administration approved nivolumab (Opdivo®, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). Efficacy was evaluated in CHECKMATE-901 (NCT03036098), a randomized, open-label trial enrolling 608 patients with previously untreated unresectable or metastatic UC. Patients were randomized (1:1) to receive either nivolumab in combination with cisplatin and gemcitabine (up to 6 cycles) followed by nivolumab alone for up to two years or cisplatin and gemcitabine (up to 6 cycles). <Read More> 

Besponsa (inotuzumab ozogamicin) for Injection – New Label Expansion – March 6, 2024 – The Food and Drug Administration approved inotuzumab ozogamicin (Besponsa®, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy was evaluated in a multicenter, single-arm, open-label study in 53 pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor ALL. Two dose levels were evaluated–an initial dose of 1.4 mg/m2/cycle in 12 patients and 1.8 mg/m2/cycle in 41 patients. <Read More>

New Drug Shortage

March 18, 2024

March 15, 2024

March 11, 2024

Updated Drug Shortage

March 19, 2024

March 18, 2024

March 15, 2024

March 13, 2024

March 12, 2024

New Drug Recall and Safety Alerts

Treprostinil Injection by Par Pharmaceuticals – New Voluntary Recall – March 12, 2024 – Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution. <Read More>

New Generic/Biosimilar Approval and Launch

Jubbonti® (denosumab-bbdz) and Wyost® (denosumab-bbdz) Injections – New Biosimilar Approvals – March 5, 2024 – FDA approved Jubbonti® (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia® (denosumab), and Wyost® (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva® (denosumab). These products bind to RANKL (receptor activator of nuclear factor kappa beta ligand), blocking its ability to bind to its receptor, a protein called RANK. Inhibition of the RANKL/RANK interaction helps prevent bone cells called osteoclasts from breaking down bone in the body. This is the first interchangeable biosimilar for a RANKL inhibitor. <Read More>

Tyenne® (tocilizumab-aazg) Injection – New Biosimilar Approval – March 5, 2024 – Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra® (tocilizumab). Tyenne® becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the U.S. commencing on the license dates, which are confidential. <Read More>

Clinical and Pharmacy News

The Future of Medicare Advantage – March 13, 2024 – The undeniable story of early 2024 for US health insurers has been the sustained economic pressures that Medicare Advantage (MA) payers are experiencing. This was borne out in 2023 year-end financial results, with several MA payers pointing to inpatient and outpatient care utilization being higher than expected, consequently increasing the medical-loss ratio. Looking ahead, the financial pressure on payers could worsen. In its 2025 advance notice for new payment rates, the US Centers for Medicare & Medicaid Services (CMS) notes that there will be an aggregate revenue growth (3.7 percent) when the increase (3.86 percent) driven by the risk score trend is included. Payers’ estimates of this number, however, vary widely. <Read More>

Eli Lilly Partners With Amazon Pharmacy for Home Delivery of its Weight Loss, Diabetes and Migraine Drugs – March 13, 2024 – Eli Lilly is partnering with Amazon’s pharmacy unit to offer home delivery for diabetes, migraine and obesity medications, including GLP-1 weight loss drug Zepbound™. The drugmaker launched its direct-to-consumer service, LillyDirect, in January to provide consumers access to telehealth and pharmacy services and the ability to get some medications directly from the company via online pharmacies. Lilly selected Amazon Pharmacy to serve as a third-party dispensing provider for LillyDirect Pharmacy Solutions, delivering prescribed Lilly medications directly to a patient’s home, according to an Amazon Pharmacy blog post. <Read More>

Oregon Set to Tighten Rules for Pharmacy Benefit Managers. Here’s What They Do – March 10, 2024 – The Legislature passed a bill tightening regulations on companies that serve as pharmacy benefit managers. House Bill 4149 will require the pharmaceutical middlemen to apply for licensing from the state among other new rules. The bipartisan bill passed with overwhelming majorities in both the House and Senate. It now heads to Gov. Tina Kotek for a signature. But what exactly is a pharmacy benefit manager? To help us demystify them, OPB “Weekend Edition” host Lillian Karabaic talked to Crystal Ligori about what exactly they are. <Read More>

Prevalence of Self-Reported Hypertension and Antihypertensive Medication Use Among Adults — United States, 2017–2021 – March 7, 2024 – Hypertension, or high blood pressure, is a major risk factor for heart disease and stroke. It increases with age and is highest among non-Hispanic Black or African American persons, men, persons aged ≥65 years, those of lower socioeconomic status, and those who live in the southern United States. Hypertension affects approximately one half of U.S. adults, and approximately one quarter of those persons have their blood pressure under control…Increases in antihypertensive medication use were observed in most sociodemographic groups and in many states. Assessing current trends in hypertension diagnosis and treatment can help guide the development of policies and implementation of interventions to reduce this important risk factor for cardiovascular disease and can aid in addressing health disparities. <Read More>

Veklury® Appears to Reduce Risk for Long COVID – March 7, 2024 – Remdesivir (Veklury®, Gilead) appears to reduce the risk for certain long COVID-19 symptoms in people who were hospitalized for COVID-19, according to data presented at CROI 2024. To understand remdesivir’s potential effect on the risk for long COVID, Gilead researchers analyzed HealthVerity data from 52,006 patients. They found using remdesivir, a nucleotide analog prodrug, was associated with a 10% lower risk for any long COVID symptom in patients younger than 65 years (hazard ratio [HR], 0.90; 95% CI, 0.86-0.93) and in those 65 and older (HR, 0.90; 95% CI,0.86-0.95). <Read More>

Biden Is Right. The US Generally Pays Double That of Other Countries for Rx Drugs – March 6, 2024 – It’s well documented that Americans pay high prices for health care. But do they pay double or more for prescriptions compared with the rest of the world? President Joe Biden said they did. “If I put you on Air Force One with me, and you have a prescription — no matter what it’s for, minor or major — and I flew you to Toronto or flew to London or flew you to Brazil or flew you anywhere in the world, I can get you that prescription filled for somewhere between 40 to 60% less than it costs here,” Biden said Feb. 22 at a campaign reception in California. <Read More>

Clinical Practice Recommendations for Kidney Involvement in Tuberous Sclerosis Complex: A Consensus Statement by the ERKnet Working Group for Autosomal Dominant Structural Kidney Disorders and the ERA Genes & Kidney Working Group – March 5, 2024 – Tuberous sclerosis complex (TSC) is an autosomal dominant disorder characterized by the presence of proliferative lesions throughout the body. Management of TSC is challenging because patients have a multifaceted systemic illness with prominent neurological and developmental impact as well as potentially severe kidney, heart and lung phenotypes; however, every organ system can be involved. Adequate care for patients with TSC requires a coordinated effort involving a multidisciplinary team of clinicians and support staff…Here, we summarize the current evidence and present recommendations for the multidisciplinary management of kidney involvement in TSC. <Read More>

340B in the News

Appeals Court Affirms Arkansas Law Against Drugmakers’ 340B Contract Pharmacy Restrictions – March 13, 2024 – A federal appellate court upheld an Arkansas law prohibiting drugmakers from restricting 340B drug discounts for providers using contract pharmacies, potentially setting up other states to pass similar legislation. The ruling was handed down Tuesday by the U.S. Court of Appeals for the Eighth Circuit’s three-judge panel. The judges disagreed with a pharmaceutical industry group’s argument that Arkansas’ 340B Drug Pricing Nondiscrimination Act passed in 2021 is preempted by existing federal law outlining the program, which requires drug manufacturers to sell drugs at a discount to safety-net providers. <Read More>

 

As Urged by the AHA, 8th Circuit Upholds Arkansas Law Protecting 340B Contract Pharmacy Arrangements – March 12, 2024 – The U.S. Court of Appeals for the 8th Circuit March 12 upheld Arkansas’ 340B Drug Pricing Nondiscrimination Act against a constitutional challenge brought by the Pharmaceutical Research and Manufacturers of America, ruling that the Federal Food, Drug, and Cosmetic Act does not preempt the state law. The Arkansas law (Act 1103) prohibits drug company policies that restrict provider access to 340B discounts through community and specialty pharmacy partners. In a friend-of-the-court brief filed in the case last year, AHA argued that the Arkansas statute does not conflict with federal law, but rather supports and complements the 340B program. The court agreed. <Read More>