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
ORLYNVAH
FDA Approves Orlynvah for the Treatment of Uncomplicated Urinary Tract Infections
October 25, 2024 – Iterum Therapeutics plc announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum.
- Orlynvah is a novel oral penem antibiotic for the treatment of uUTI. Orlynvah possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins.
- There are approximately 40 million uUTI prescriptions generated annually in the United States, and it is estimated approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics.
Source: Iterum Therapeutics PLC
VYLOY™
FDA Approves Vyloy for the Treatment of Advanced Gastric and GEJ Cancer
October 18, 2024 – Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.
- Gastric and gastroesophageal junction (G/GEJ) cancer is the fifth most commonly diagnosed cancer worldwide.
- Vyloy is the first and only CLDN18.2-targeted therapy approved in the U.S.
Source: Astellas Pharma US, Inc.
VYALEV
FDA Approves Vyalev for Adults Living with Advanced Parkinson’s Disease
October 17, 2024 – AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).
- PD is a progressive and chronic movement disorder resulting in tremor, muscle rigidity, slowness of movement and difficulty with balance resulting from the loss of dopamine-producing brain cells.
- Timing for a patient’s access to Vyalev is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025.
- The majority of adverse reactions (ARs) with Vyalev were non-serious and mild or moderate in severity.
Source: AbbVie Inc.
HYMPAVZI
FDA Approves Hympavzi for the Treatment of Adults and Adolescents with Hemophilia A or B
October 11, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors.
- Hympavzi is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for the treatment of hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen. Hympavzi can offer a subcutaneous treatment option with a once-weekly dosing schedule and minimal preparation required for each individual administration.
- Discovered by Pfizer scientists, Hympavzi is a rebalancing agent that targets the Kunitz 2 domain of tissue factor pathway inhibitor (TFPI), a natural anticoagulation protein that functions to prevent the formation of blood clots and restore hemostasis.
Source: Pfizer, Inc.
ITOVEBI TABLETS
FDA Approves Itovebi for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
October 10, 2024 – Genentech announced that the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
- The PIK3CAmutation is found in approximately 40% of HR-positive metastatic breast cancers. HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.
- The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024 based on the INAVO120 study results.
- Itovebi will be available in the U.S. in the coming weeks.
Source: Genentech, Inc.
Newly Approved Indications
FDA Approves Emrosi™ for the Treatment of Rosacea
November 04, 2024 – Journey Medical has announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Emrosi was developed in collaboration with Dr. Reddy’s Laboratories Ltd.
- Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia).
- In two Phase 3 clinical trials, Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count in both studies.
Source: Journey Medical Corporation
Biosimilars
IMULDOSA Injection
FDA Approves Imuldosa, a Biosimilar to Stelara
October 14, 2024 – Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Imuldosa (ustekinumab-srlf), a biosimilar to Stelara (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The FDA approved Imuldosa for all indications of its reference medicine, Stelara.
- FDA approval of Imuldosa was granted based on a comprehensive clinical development program. The data showed that Imuldosa is similar to its reference product Stelara in terms of pharmacokinetic characteristics, safety, tolerability, efficacy and that Imuldosa adheres to current biosimilar guidance from the FDA.
- Imuldosa has the potential to be an affordable treatment option that provides similar benefits to the current standard of care.
Source: Accord BioPharma
Generic Drug Approvals
- Minocycline Hydrochloride Injection 100mg (base)/vial
Approved: October 24, 2024 – Nexus Pharmaceuticals, Inc.
Treatment for: Bacterial Infections
Generic: Minocin Injection
Recalls
Staska Pharmaceuticals, Inc. Issues Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles
October 16, 2024 – Staska Pharmaceuticals, Inc. is voluntarily recalling one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.
The Ascorbic Acid Solution for Injection is used as a vitamin supplement and is packaged in amber colored vials and the affected lot is SP2400058 with an expiration date of 12/31/2024. The product was distributed nationwide to licensed healthcare providers between 07/31/2024 and 08/27/2024.
The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities, and the presence or absence of vascular anomalies.
To date, Staska Pharmaceuticals has not received any reports of the presence of particulate matter, nor any adverse events related to this recall.
Consumers with questions regarding this recall can contact STASKA PHARMACEUTICALS at 402-782-2207 or 888-801-1370, Monday through Friday, 8am-5pm CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Source: FDA
C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients
October 16, 2024 – C&A Naturistics is voluntarily recalling all lots of AK Forte, 400mg tablets, to the consumer level. FDA analysis has found the product to be tainted with diclofenac, dexamethasone, and methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot be marketed as dietary supplements. AK Forte tablets is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
AK Forte is marketed as a dietary supplement for joint pain and arthritis and is packaged in a card-box type of packaging, with white, blue, red and gold logo of AK with a gold crown on top with 100 tablets per units, and all codes. C&A Naturistics is notifying its distributors and customers and is arranging for return/replacement etc. of all recalled products.
Consumers with questions regarding this recall can contact the company by phone 619-498-9811 or naturisticsca@gmail.com, Monday through Friday, 10am-7pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.