Sandoz has announced the US Food and Drug Administration (FDA) approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu would be interchangeable with the reference medicine, as it is currently subject to unexpired exclusivity for the first interchangeable biosimilar products.
nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.
Eli Lilly and Company announced Zepbound® (tirzepatide) 2.5mg and 5mg single-dose vials are available for self-pay for patients with an on-label prescription, significantly expanding the supply of Zepbound in response to high demand.
The single-dose vials are priced at a 50% or greater discount compared to the list price of all other incretin (GLP-1) medicines for obesity. This new option helps millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage, and those who need to self-pay outside of insurance.
Lilly has created a new self-pay pharmacy component of LillyDirect where patients with a valid, on-label prescription from the health care provider of their choice can purchase the vials. Distributing the vials via this channel ensures patients and providers can trust they are receiving genuine Lilly medicine, building on the company’s efforts to help protect the public from the dangers posed by the proliferation of counterfeit, fake, unsafe or untested knock-offs of Lilly’s medications. The self-pay channel enables a transparent price by removing third party supply chain entities and allowing patients to access savings directly outside of insurance. A four-week supply of the 2.5mg Zepbound single-dose vial is $399 ($99.75 per vial), and a fourweek supply of the 5mg dose is $549 ($137.25 per vial) – less than half the list price of other incretin medicines for obesity and in line with the Zepbound savings program for non-covered individuals.
Lilly has also taken a vocal stance against the use of obesity medicine for cosmetic weight loss; a multi-step verification process will help ensure the vials are dispensed only to patients who have a valid, on-label electronic prescription from their health care provider. Patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.
“People living with obesity have long been denied access to the essential treatment and care needed to manage this serious chronic disease,” said James Zervos, chief operating officer, Obesity Action Coalition. “Expanding coverage and affordability of treatments is vital to people living with obesity. We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality. Now, it’s time for policymakers, employers and insurers to work with pharmaceutical companies to ensure no one is left behind in receiving the care they deserve and need.”
The U.S. Food and Drug Administration (FDA) announced the approval of Pavblu (aflibercept-ayyh) 2mg injection (single-dose prefilled syringe and single-dose vial) for intravitreal administration.
Pavblu is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: o Neovascular (Wet) Age-Related Macular Degeneration (AMD) o Macular Edema Following Retinal Vein Occlusion (RVO) o Diabetic Macular Edema (DME) o Diabetic Retinopathy (DR)
Pavblu is biosimilar to the reference product Eylea, and does not have an interchangeability designation.The FDA granted Amgen, Inc. approval for Pavblu based on analytical and preclinical in vitro study data, and clinical data.
The active ingredient in Pavblu is aflibercept. Aflibercept is a recombinant fusion protein that works by blocking vascular endothelial growth factor (VEGF) to prevent abnormal blood vessel growth within the eye, and to slow down or reduce damage to the retina and help preserve vision.
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2
Moderna, Inc. announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above.
Emergency Use Authorization (EUA) for the Moderna’s COVID-19 Vaccine (2024-2025 formula) was also granted for individuals 6 months through 11 years of age.
Moderna’s updated COVID-19 vaccine targets the KP.2 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA’s decision, Moderna’s updated vaccine is expected to be available in the coming days.
Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli (eculizumab-aagh) infusion as a biosimilar to Soliris (eculizumab).
Epysqli has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
Epysqli is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
FDA Approves Rybrevant plus Lazcluze for Patients with EGFR-Mutated Advanced Lung Cancer
Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved Rybrevant® (amivantamab-vmjw) plus Lazcluze™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions, or exon 21 L858R substitution mutations, as detected by an FDAapproved test.
With this milestone, Rybrevant® plus Lazcluze™ becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib (Tagrisso®) for the first-line treatment of patients with EGFR-mutated NSCLC.
Rybrevant® is an EGFR- and MET*
directed bispecific antibody that engages the immune system, and Lazcluze™ is a highly selective, brain-penetrant, third-generation oral EGFR TKI. Rybrevant® plus Lazcluze™ is the only regimen targeting both of the common EGFR mutations directly.
FDA Grants Accelerated Approval for Livdelzi for the Treatment of Primary Biliary Cholangitis
Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) granted accelerated approval for Livdelzi(seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
The accelerated approval was based primarily on data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12, versus 20% of participants taking placebo.
Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s).
Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the Potential for Particulate Matter and Leakage
B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.
The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
Risk Statement: There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.
B. Braun has notified its distributors and customers by an official recall notice sent via certified registered mail and has arranged for the return of all recalled products. Facilities and distributors that have the product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return.
Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to B. Braun’s Postmarket Surveillance Department by calling 1-833-425-1464.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug
No members of BeneCard PBF were affected by this recall. Administration.
FDA Approves Crexont Extended-Release Capsules for the Treatment of Parkinson’s Disease
Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD).
Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediaterelease (IR) granules and extended-release (ER) pellets. Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses.
There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes.
Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
Baxter International Inc. is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.
Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.
Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000mL in VIAFLEX Plus Plastic Container-1 unit per pouch. This issue affects one lot of product code that was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers and distributors in the United States. The product code and lot number can be found on the individual product and shipping carton. See the table below for more information.
Baxter voluntarily sent an Urgent Drug Recall communication to all impacted customers for the impacted lot and is arranging for the return of all affected product. Customers should follow the instructions in the
Urgent Drug Recall letter to return the affected product. Customers with questions regarding this recall should contact Baxter Healthcare Center for Service at (888)-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Contacting Baxter Product Surveillance at the Baxter product feedback portal at https://productfeedback.baxter.com or emailing Baxter at corporate_product_complaints_round_lake@baxter.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. No members of BeneCard PBF were affected by this recall. Source: FDA
