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Clinical Insights: May 1, 2024

Posted on May 1, 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

Beqvez™ (fidanacogene elaparvovec-dzkt) Injection – New Drug Approval – April 26, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Beqvez™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. Beqvez™ is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month. <Read More>

Pivya™ (pivmecillinam) Tablets – New Drug Approval – April 24, 2024 – The U.S. Food and Drug Administration approved Pivya™ (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus…Pivya™’s efficacy in treating females 18 years of age or older with uncomplicated UTIs was assessed in three controlled clinical trials comparing different Pivya™ dosing regimens to placebo, to another oral antibacterial drug and to ibuprofen (an anti-inflammatory drug). <Read More>

Ojemda™ (tovorafenib) Tablets and Oral Suspension – New Drug Approval – April 23, 2024 – The Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda™, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions. Efficacy was evaluated in 76 patients enrolled in FIREFLY-1 (NCT04775485), a multicenter, open-label, single-arm trial in patients with relapsed or refractory pediatric LGG harboring an activating BRAF alteration detected by a local laboratory who had received at least one line of prior systemic therapy. <Read More>

Anktiva® (nogapendekin alfa inbakicept-pmln) – New Drug Approval – April 22, 2024 – The Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva®, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Efficacy was evaluated in QUILT-3.032 (NCT0302285), a single-arm, multicenter trial of 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection. Patients received nogapendekin alfa inbakicept-pmln induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months. <Read More>

Lumisight™ (pegulicianine) for Injection – New Drug Approval – April 17, 2024 – FDA has approved Lumisight™ (pegulicianine) in adults with breast cancer to assist the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Lumisight™ is a fluorescent imaging drug that is administered in the form of an intravenous injection before surgery. Lumisight™ is used with the Lumicell Direct Visualization System (DVS) or another fluorescence imaging device that is FDA-approved for use with pegulicianine for breast lumpectomy surgery. <Read More>

New Indication/Dosage/Formulation Approval

Lutathera® (lutetium Lu 177 dotatate) Injection – New Label Expansion – April 23, 2024 – Novartis announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. This approval makes Lutathera® the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs. <Read More>

Entyvio® (vedolizumab) Injection – New Label Expansion – April 18, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved Entyvio® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) Entyvio®. The subcutaneous administration of Entyvio® was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (Entyvio® Pen). <Read More>

Alecensa® (alectinib) Capsules – New Label Expansion – April 18, 2024 – The Food and Drug Administration approved alectinib (Alecensa®, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Efficacy was demonstrated in a global, randomized, open-label trial (ALINA, NCT03456076) in patients with ALK-positive NSCLC who had complete tumor resection. <Read More>

New Drug Shortage

April 29, 2024

April 26, 2024 

April 23, 2024

April 17, 2024

Updated Drug Shortage

April 29, 2024

April 26, 2024

April 25, 2024

April 24, 2024

April 23, 2024

New Drug Recall and Safety Alerts

Sapropterin Dihydrochloride Powder for Oral Solution 100 mg by Dr. Reddy’s – New Voluntary Recall – April 23, 2024 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints. <Read More>

New Generic/Biosimilar Approval and Launch

Selarsdi™ (ustekinumab-aekn) Injection – New Biosimilar Approval – April 16, 2024 – Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Selarsdi™ (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of Selarsdi™ in the United States. <Read More>

Clinical and Pharmacy News

Hagens Berman Signals Major Turning Point in Insulin Fair Pricing Class-Action Lawsuit – April 23, 2024 – A historic fair drug-pricing lawsuit has reached a milestone moment, according to attorneys at Hagens Berman and Carella Byrne Cecchi Olstein Brody & Agnello who represent a class of those living with diabetes fighting the rising price of insulin. The law firms first began the crusade against insulin-maker Eli Lilly in 2017 and have been leading the charge to make a difference for the millions of people who rely on insulin on a daily basis, and recent activity from the court has spurred attorneys in a new direction. “Since we began this case, we’ve received calls, emails and messages from individuals underscoring the drastic need for change,” said Steve Berman, managing partner and co-founder of Hagens Berman and court-appointed co-lead counsel representing insulin purchasers in the lawsuit. “When drug makers charge prohibitively high prices for life-saving medication, a lawsuit like this truly has the potential to save lives.” <Read More>

FTC Looking to Accelerate Inquiry Into Prescription-Drug Middlemen, Chair Says – April 23, 2024 – Drug patents that can keep prescription prices artificially high are also set for more scrutiny, according to Lina Khan. The Federal Trade Commission is working to accelerate its inquiry into the prescription-drug middlemen known as pharmacy-benefit managers, while also expanding its scrutiny of drug patents that can keep prescription prices artificially high, FTC Chair Lina Khan told reporters Tuesday. Khan said the agency is “proceeding as expeditiously as we can” on the pharmacy-benefit manager inquiry, which launched in 2022 and aims to examine the industry’s methods for determining pharmacy reimbursement, tactics that may steer patients toward PBM-owned pharmacies, and other issues. <Read More>

New Guidelines Recommend GLP-1 Drugs Such as Ozempic® to Help Treat Type 2 Diabetes in Adults – April 19, 2024 – Medications such as Jardiance® and Ozempic® can help people with type 2 diabetes who have trouble controlling their blood sugar when the drugs are used in conjunction with the diabetes medication metformin as well as interventions to improve diet and exercise. That’s what the American College of Physicians (ACP) is saying in their newly revised clinical recommendations published in the Annals of Internal Medicine. <Read More>

New Research Highlights Premium Impact of Provider Markups on Specialty Drugs Universities Are Profiting From Blocking Drug-Price Reform – April 17, 2024 – Research universities, many of them public, have joined forces with pharmaceutical companies and Wall Street firms to fight new government efforts to curtail out-of-control drug prices, saying the regulations could stifle innovation. But these universities are also likely concerned that drug-price reforms would hamper their profits. Case in point: the University of California, Los Angeles (UCLA) has quietly reaped more than a billion dollars in payouts from Xtandi®, a lifesaving cancer drug that it developed with the help of government funding and now costs US patients $200,000 a year. <Read More>

A Practical Approach for Vaccinating Adults Living With HIV – April 17, 2024 – In the fast-paced environment of outpatient medicine with ever-encroaching requirements, staying up to date with the latest recommendations and changes in vaccination guidelines can feel like navigating a constantly shifting terrain. This rings especially true for clinicians who are tasked with caring for people living with HIV, where considerations for immunizations can become particularly nuanced. HIV-associated immune decline can impair both cellular and humoral immunity, mandating a proactive approach to prevent disease through vaccination. <Read More>

340B in the News

HHS Finalizes Rule on 340B Administrative Dispute Resolution Process – April 18, 2024 – The Department of Health and Human Services finalized its rule to establish a 340B Administrative Dispute Resolution process as required under the Affordable Care Act. The rule establishes an ADR process that allows all 340B covered entities, regardless of the size of the organization or monetary value of the claim, to avail themselves of this important process to address claims at dispute with drug companies. Specifically, the new finalized ADR process would:  1) Create a more conventional administrative process that is less trial-like consisting of 340B program subject matter experts from the Health Resources and Services Administration’s Office of Pharmacy Affairs, 2) Allow covered entities to bring forth claims where they have been overcharged by a drug company including where the drug company or its wholesaler denies access to 340B pricing… <Read More>