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Clinical Insights: April 3, 2024

Posted on April 3, 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

Voydeya™ (danicopan) Tablets – New Drug Approval – March 29, 2024 – Voydeya™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). Voydeya™ is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris® (ravulizumab) or Soliris® (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor. <Read More> 

Vafseo® (vadadustat) Tablets – New Drug Approval – March 27, 2024 – Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo® is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo® is now approved in 37 countries. <Read More>

Winrevair™ (sotatercept) for Injection – New Orphan Drug Approval – March 26, 2024 – Merck (NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: Winrevair™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. Winrevair™ was previously granted Breakthrough Therapy Designation by the FDA. Winrevair™ is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. <Read More>

Opsynvi® (macitentan and tadalafil) Tablets – New Orphan Drug Approval – March 22, 2024 – Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. Opsynvi® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. Opsynvi® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets. <Read More>

Duvyzat™ (givinostat) Oral Suspension – New Orphan Drug Approval – March 21, 2024 – The U.S. Food and Drug Administration approved Duvyzat™ (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat™ is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle. <Read More>

Tryvio™ (aprocitentan) Tablets – New Drug Approval – March 20, 2024 – Idorsia Ltd (SIX: IDIA) announced that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of Tryvio™ is 12.5 mg orally once daily, with or without food. <Read More>

New Indication/Dosage/Formulation Approval

Vemlidy® (tenofovir alafenamide) Tablets – New Label Expansion – March 27, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. <Read More>

Elahere® (mirvetuximab soravtansine-gynx) Injection – New Label Expansion – March 22, 2024 – AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Elahere® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as Elahere®. <Read More>

Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid and ezetimibe) Tablets – New Label Expansion – March 22, 2024 – Esperion (NASDAQ: ESPR) announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for Nexletol® (bempedoic acid) Tablets and Nexlizet® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of Nexletol® and Nexlizet® either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients. <Read More> 

Ultomiris® (ravulizumab-cwvz) Injection – New Label Expansion – March 22, 2024 – Ultomiris® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval by the US Food and Drug Administration (FDA) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were published in the Annals of Neurology. In the trial, Ultomiris® was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial. <Read More>

Ixinity® (coagulation factor IX (recombinant)) for Injection – New label Expansion – March 22, 2024 – Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) announced that the US Food and Drug Administration (FDA) recently approved Medexus’s supplemental Biologics License Application (sBLA) for Ixinity® [coagulation factor IX (recombinant)] for the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of age with hemophilia B. Ixinity®, an intravenous recombinant factor IX therapeutic, is now approved for use in all patients with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. <Read More>

Iclusig® (ponatinib) Tablets – New Label Expansion – March 19, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This accelerated approval application was granted Priority Review and evaluated under the Real-Time Oncology Review (RTOR) program, an FDA initiative designed to expedite the delivery of cancer medicines by allowing components of an application to be reviewed before submission of the complete application. <Read More>

Spevigo® (spesolimab-sbzo) Injection – New Label Expansion – March 18, 2024 – Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved Spevigo® (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing ≥40 kg. This approval follows the Chinese National Medical Products Administration’s (NMPA) recent approval of Spevigo® for the reduction of occurrence of generalized pustular psoriasis (GPP) in adolescents from 12 years of age with a body weight ≥40 kg and adults. Spevigo® is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP. <Read More>

New Drug Shortage

March 28, 2024

March 27, 2024 

March 26, 2024

March 25, 2024

March 22, 2024

Updated Drug Shortage

April 02, 2024

April 01, 2024

March 29, 2024

March 28, 2024

March 25, 2024

New Drug Recall and Safety Alerts

Atovaquone Oral Suspension, USP 750 mg/5 mL by AvKARE, LLC. – New Voluntary Recall – April 1, 2024 – AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. <Read More>

Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) by Eugia US LLC (f/k/a AuroMedics Pharma LLC) – New Voluntary Recall – March 28, 2024 – Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) – 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating inside of the vial. <Read More>

Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL by Amneal Pharmaceuticals, LLC. – New Voluntary Recall – March 27, 2024 – Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Biden-Harris Administration Furthers Medicare Drug Price Negotiations, Releases New Data on How the President’s Historic Law Lowers Health Care Costs for Women – April 2, 2024 – The Inflation Reduction Act’s Medicare drug price negotiations and other provisions will lower the cost of prescription drugs for millions of women. The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. Also, HHS announced that the Centers for Medicare & Medicaid Services (CMS) responded to counteroffers from all manufacturers participating in Medicare drug price negotiations – which the Inflation Reduction Act made possible – and invited them to participate in further discussions. <Read More> 

Highly Pathogenic Avian Influenza A (H5N1) Virus Infection Reported in a Person in the U.S. – April 1, 2024 – A person in the United States has tested positive for highly pathogenic avian influenza (HPAI) A(H5N1) virus (“H5N1 bird flu”), as reported by Texas and confirmed by CDC. This person had exposure to dairy cattle in Texas presumed to be infected with HPAI A(H5N1) viruses. The patient reported eye redness (consistent with conjunctivitis), as their only symptom, and is recovering. The patient was told to isolate and is being treated with an antiviral drug for flu. This infection does not change the H5N1 bird flu human health risk assessment for the U.S. general public, which CDC considers to be low. <Read More>

Study: ‘Gamechanger’ Diabetes Drugs Cost up to 400 Times More Than Needed – March 28, 2024 – Drug companies are pricing diabetes medicines at almost 400 times the level necessary to make a profit, according to a new study. Researchers said it would also be possible for modern insulin pens, which are safer and offer more accurate doses than vials and syringes, to be used even in low-income countries if pharmaceutical firms “put people before their astronomical profits”. A new generation of diabetes drugs known as GLP-1 receptor agonists (GLP-1s) include Novo Nordisk’s Ozempic® (semaglutide), taken by some celebrities as a weight-loss aid, and Eli Lilly’s Trulicity® (dulaglutide). They are now a standard part of treatment in high-income countries, but are unaffordable in many parts of the world despite rising rates of the condition. <Read More>

ASCO Updates Guidelines on Vaccines in Patients with Cancer – March 27, 2024 – The American Society of Clinical Oncology (ASCO) recently issued a new clinical practice guideline, “Vaccinations of Adults with Cancer,” updating its recommendations for patients with cancer of which vaccines to receive. For adult patients of all ages, the guideline recommends: 1) Influenza vaccine annually, 2) COVID-19 vaccine according to the recommended CDC schedule, 3) Tdap or Td vaccine once, followed by a booster every 10 years, 4) Two doses of recombinant zoster vaccine at least 4 weeks apart, 5) One dose of PCV20 pneumococcal vaccine or 1 dose of PCV15 followed by PPSV23 8 weeks later. <Read More> 

The Truth About Compounded GLP-1s That Doctors Need to Know – March 26, 2024 – Meanwhile, the APC statement notes, Novo Nordisk and Eli Lilly have sued compounding companies in several states, questioning, among other things, the purity and potency of some compounded products. There are different designations for compounding pharmacies: 503A and 503B. 503As are state-licensed pharmacies and physicians, and 503B pharmacies are federally regulated outsourcing facilities that are strictly regulated by the FDA. This regulation, established following a 2012 fungal meningitis outbreak linked to a compounding pharmacy, ensures higher-quality control and oversight, especially for medications intended for intravenous or epidural use. These standards exceed those required for subcutaneous injections like GLP-1 analogs. <Read More>

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects – March 26, 2024 – The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law. Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. <Read More>

340B in the News

Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future. – March 26, 2024 – Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1st to submit comments to legislators regarding the Discussion Draft Explanatory Statement and Supplemental RFI (the “RFI”) of the “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act” (the “Sustain 340B Act”). This bipartisan legislative discussion draft was released by the Senate 340B Working Group (the “Working Group”) earlier this year, to update the 340B Program. <Read More>