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).
FDA Approves Niktimvo for the Treatment of Chronic Graft-Versus-Host Disease
Incyte and Syndax Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved Niktimvo (axatilimab-csfr), a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40kg (88.2lbs).
Chronic GVHD is a serious condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs.
Chronic GVHD is a leading cause of significant morbidity and mortality after an allogeneic stem cell transplant and is estimated to develop in approximately 42% of transplant recipients, affecting approximately 17,000 patients in the U.S. Of those patients who develop chronic GVHD, nearly 50% require at least three lines of treatment, emphasizing the need for additional effective treatment options.
FDA Approves Nemluvio for the Treatment of Adult Patients with Prurigo Nodularis
Galderma announced the U.S. Food and Drug Administration (FDA) approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.
Nemluvio was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA – a status reserved for medicines with the potential to significantly improve the treatment of serious conditions.
Prurigo nodularis is an underdiagnosed neuroimmune skin disease which is estimated to affect up to 181,000 people in the United States, and is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality.
Nemluvio specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.
FDA Approves Yorvipath for the Treatment of Hypoparathyroidism in Adults
Ascendis Pharma A/S announced the U.S. Food & Drug Administration (FDA) approved Yorvipath (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults.
Yorvipath is a prodrug of parathyroid hormone (PTH[1-34]), administered once daily, designed to provide continuous exposure to released PTH over the 24-hour dosing period.
Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs and affects an estimated 70,000 to 90,000 people in the United States.
FDA Approves neffy® (epinephrine nasal spray) Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
ARS Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved neffy® (epinephrine nasal spray) 2mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30kg (66lbs).
The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.
Type I allergic reactions, including those caused by food, medications, and insect bites, can lead to lifethreatening anaphylaxis and result in an estimated 500,000 emergency room (ER) visits each year, with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ER.
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 Lymphir Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Citius Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
Lymphir is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant Tcells and Tregs. This is the first indication for Lymphir and the first FDA-approved product for Citius Pharma.
Lymphir provides another viable option in the treatment landscape with unique benefits to patients. It offers a novel mechanism of action designed to target and eradicate malignant T-cells while preserving healthy tissue. It is the only treatment option that targets the IL-2 receptors found in T-cell lymphomas and Tregs.
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.
