Mar 15, 2024 | Posted in Drug News

Drug News – March 2024

BeneCard PBF compiles the latest pharmacy news from across the web, including new drug approvals, recalls, new generic drug approvals and more.  The content is the property of the website owners, writers and contributors.

New Drug Approvals


FDA Approves Exblifep for the Treatment of Complicated Urinary Tract Infections

February 27, 2024 – Allecra Therapeutics (“Allecra”) announced that the U.S. Food and Drug Administration has approved Exblifep as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act). The GAIN Act, enacted by the U.S. Congress, incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of Qualified Infectious Disease Products (QIDPs).

Exblifep is a combination antibiotic used for complicated urinary tract infections (cUTIs) that contains two antibiotics, cefepime and enmetazobactam. Exblifep is used when the bacteria causing the UTI is resistant to other antibiotics, especially if the resistance is due to Extended Spectrum Beta Lactamases (ESBLs).

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FDA Grants Accelerated Approval for Amtagvi (lifileucel) for the Treatment of Advanced Melanoma

February 16, 2024 – Iovance Biotherapeutics, Inc, announced that the U.S. Food and Drug Administration (FDA) has approved Amtagvi™ (lifileucel) suspension for intravenous infusion. Amtagvi is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Amtagvi is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. The proposed mechanism for Amtagvi offers a new cell therapy approach that deploys patient-specific T cells called tumor-infiltrating lymphocyte (TIL) cells. When cancer is detected, the immune system creates T cells to locate, attack, and destroy cancer. When cancer develops and prevails, the body’s natural T cells can no longer perform their intended function to fight cancer. Amtagvi’s TIL cells are designed to recognize distinctive tumor markers on the cell surface of each person’s cancer.

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FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines

March 4, 2024 – Hugel America, Inc., a division of Hugel Inc.,  today announced it received U.S. Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults. In the coming months, Hugel plans to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the back half of 2024.

FDA approval is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the U.S. and Europe. This botulinum toxin type A has been the leading neurotoxin brand in South Korea, one of the world’s most dynamic aesthetic markets, for seven consecutive years. Hugel has sold over 26 million vials in 50+ different countries including Australia, Canada, and Europe.

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FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite

February 14, 2024 – The U.S. Food and Drug Administration (FDA) approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The FDA granted the approval of Aurlumyn to Eicos Sciences Inc.

Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation. Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting.

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Bio Similar Approvals


FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra

March 7, 2024 – Fresenius Kabi, announced today that the 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.

Tyenne has launched globally in more than 10 countries, with plans to launch in many more countries between 2024 and 2025. Tyenne (tocilizumab-aazg) is FDA approved for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

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FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva

March 5, 2024 – Sandoz, announced that the U.S. Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva.

Wyost is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

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FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia

March 5, 2024 – Sandoz, has announced that the U.S. Food and Drug Administration approved Jubbonti, (denosumab-bbdz), an interchangeable biosimilar to Prolia.

Jubbonti is approved to:

  • Treat postmenopausal women with osteoporosis at high risk for fracture.
  • Increase bone mass in men with osteoporosis at high risk for fracture.
  • Treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
  • Increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
  • Increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

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FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira

February 24, 2024 – Alvotech and Teva Pharmaceuticals, have announced that the U.S. Food and Drug Administration (FDA) has approved Simlandi (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion. Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi in the United States.

Simlandi is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88 percent of U.S. prescriptions for adalimumab are for the high-concentration presentation.

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Newly Approved Indications


Rybrevant® in Combination with Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

March 1, 2024Johnson & Johnson has announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved Rybrevant® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test. This FDA action converts the May 2021 accelerated approval of Rybrevant® to a full approval based on the confirmatory Phase 3 PAPILLON study.

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in NSCLC. Clinical data show patients with EGFR exon 20 insertion mutations generally experience limited benefits with currently approved third-generation EGFR tyrosine kinase inhibitors and chemotherapy. NSCLC driven by EGFR exon 20 insertion mutations carries a worse prognosis and shorter survival rates compared with lung cancer driven by other EGFR driver mutations.

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Lantheus Announces the FDA Approval of Definity (Perflutren Lipid Microsphere) for Pediatric Patients

March 4, 2024 – Lantheus Holdings, Inc, has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Definity® (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms. This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border. Currently, Definity is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.

Clinical studies have substantiated the efficacy and safety of Definity in pediatric patients.

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U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-Existing Resistance

February 26, 2024 – Gilead Sciences, Inc. has announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.

This label update is supported by Study 4030, which evaluated the efficacy, safety, and tolerability profile of Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.

Once someone with HIV has developed resistance to a treatment, it will persist for the rest of their life. Reducing the risk of drug resistance is a key goal in HIV therapy. HIV drug resistance continues to receive clinical and public health attention because it may hinder the ability of HIV medicines to suppress and block replication of the virus over the course of an individual’s life. Resistance may lead to treatment failure in individuals, while also creating the potential for transmission of treatment-resistant HIV within communities.

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FDA Approves new indication for Xolair

February 16, 2024 – The U.S. Food and Drug Administration (FDA) approved a new indication for Genentech/Novartis’ Xolair (omalizumab), an anti-immunoglobulin E (IgE) antibody. Xolair is now indicated for IgE-mediated food allergy in adult and pediatric patients 1 year of age and older for the reduction of allergic reactions (Type I). This includes anaphylaxis, that may occur with accidental exposure to one or more foods. Xolair is intended to be used in conjunction with food allergen avoidance.

Xolair was first approved in 2003 for moderate to severe persistent allergic asthma and has since been approved for perennial aeroallergen allergies, to treat chronic idiopathic urticaria, and as an add-on maintenance treatment for nasal polyps in adults with inadequate response to nasal corticosteroids.

Xolair does not treat acute allergic food reactions and does not replace the use of epinephrine for such reactions. Patients taking Xolair for food allergies may need to continue to carry epinephrine for treating emergency allergic reactions.

Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure. Aimmune Therapeutics’ Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp) is an oral immunotherapy product approved in patients 4–17 years of age for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut, but its use is restricted to peanut allergy. There are other agents in development for food allergies, including some for multiple food allergies.

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Generic Drug Approvals

  • Ospemifene Tablets 60 mg
    Approved: February 13, 2024 – Hetero Labs Limited
    Treatment for: Menopause Symptoms
    Generic for: Osphena

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