FDA Approves Pavblu (aflibercept-ayyh), a Biosimilar to Eylea

Follow Drugslib on

FDA Approves Pavblu (aflibercept-ayyh), a Biosimilar to Eylea

August 23, 2024 – The U.S. Food and Drug Administration (FDA) has announced the approval of Pavblu (aflibercept-ayyh) 2 mg injection (single-dose prefilled syringe and single-dose vial) for intravitreal administration. Pavblu is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and 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.

About Pavblu (aflibercept-abzv)

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.

INDICATIONSPavblu is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:• Neovascular (Wet) Age-Related Macular Degeneration (AMD)• Macular Edema Following Retinal Vein Occlusion (RVO) • Diabetic Macular Edema (DME)• Diabetic Retinopathy (DR)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS• Ocular or periocular infection• Active intraocular inflammation• Hypersensitivity

WARNINGS AND PRECAUTIONS• Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

ADVERSE REACTIONSThe most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

This is not the complete list of all the safety information for Pavblu.

Reference: Pavblu Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761298s000lbl.pdf Accessed August 23, 2024

Posted : 2024-09-04 15:23

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords