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FDA Approves Enzeevu, a Biosimilar to Eylea

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.

Source: Sandoz

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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.”

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FDA Approves Pavblu, a Biosimilar to Eylea

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.

Source: FDA

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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.

SOURCE: Moderna, Inc.

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FDA Approves Epysqli, a Biosimilar to Soliris

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).

Source: Samsung Bioepis Co., Ltd.

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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.

Source: Johnson & Johnson

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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).

Source: Gilead Sciences, Inc.

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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.

Source: Incyte and Syndax Pharmaceuticals

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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.

Source: Ascendis Pharma

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