Fuzeon Discontinued in the U.S. Market
Genentech will stop marketing and commercial distribution in the U.S. for its drug Fuzeon® (enfuviritide) on Feb. 28, 2025. The decision was not related to any safety, quality or efficacy issues. Fuzeon is indicated to treat HIV-1 infection, in combination with other antiretroviral (ARV) drugs, in treatment experienced individuals with HIV-1 replication despite ongoing ARV therapy. Fuzeon is a viral envelope glycoprotein (gp41) fusion inhibitor that contains enfuviritide 108mg per vial powder for subcutaneous (SC) injection. By inhibiting the fusion of the HIV molecule and the cellular membrane of the cell, Fuzeon works by blocking the entry of HIV1- molecules into healthy cells. The recommended dose is 90mg twice per day given as a SC injection for individuals over 16 years of age. In children less than six to 16 years of age the recommended dose 2mg/kg twice daily with a maximum dose of 90mg twice per day. Anyone impacted by the recall can reach the Fuzeon support line at 1.877.438.9366. Fuzion is no longer protected under patent protection and it generated less than $10 million in annual sales for 2023. For full prescribing information, see here.
Eylea Biosimilar Pavblu Approved, But Not Launched
On Aug. 23, 2024, the U.S. Food and Drug Administration (FDA) approved Amgen’s Pavblu™ (aflibercept-ayyh), another biosimilar to the vascular endothelial growth factor (VEGF) inhibitor Eylea® (aflibercept – Regeneron) injection. Pavblu is indicated for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). Eylea is approved to treat the previous indications listed along with retinopathy of prematurity (ROP). A 2mg prefilled syringe and single-dose vial were both approved for intravitreal injection. The recommended dose of Pavblu is 2mg injected intravitreally by a qualified physician in a sterile setting – usually once every month or once every two months. Pavblu is the fifth biosimilar to Eylea approved by the FDA. Others include Enzeevu™ (aflibercept-abzv – Sandoz), Opuviz™ (aflibercept-yszy – Samsung Bioepis/Biogen), Yesafili™ (aflibercept-jbvf – Biocon Biologics) and Ahzantive™ (aflibercept-mrbb – Formycon AG/Klinge Biopharma). The launch date for all Eylea biosimilars remains unknown due to ongoing patent litigation. Only Opuviz and Yesafili have interchangeability to Eylea at this time. In August 2023, Regeneron introduced an 8mg strength, Eylea® HD injection, which can be given once every two months or every four months. This new formulation is patent-protected until at least 2039. For 2023, US sales of Eylea were $6.3 billion, including about $168 million from the 8mg high dose strength. Here is its full prescribing information.
First Lucemyra Generic Approved and Launched
On Aug. 21, 2024, Indoco Remedies Limited announced the launch of lofexidine 0.18mg oral tablets, the first approved generic equivalent of Lucemyra™ (lofexidine – US WorldMeds). The FDA approved the generic version on Aug. 20, 2024. According to IQVIA, annual U.S. sales of Lucemyra are around $15.6 million. Lofexidine is a selective alpha 2-adrenergic receptor agonist indicated to mitigate symptoms associated with acute withdrawal from opioids and to facilitation the completion of opioid discontinuation treatment in adults. It is mostly used as adjunct therapy with buprenorphine or methadone. Recommended dosing is three tablets taken orally four times daily for 14 days during peak withdrawal symptoms with dosing adjustments made according to withdrawal symptoms or side effects. For prescribing information, see here.
Expanded Mpox Indication Approved for Smallpox Vaccine Emergent Biosolutions’ ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live) received an indication expansion for the prevention of human mpox disease in individuals determined to be at high risk for mpox infection on Aug. 29, 2024. Mpox, formerly known as monkeypox, is a disease caused by the monkeypox virus, which is part of the same family as the virus that causes smallpox. ACAM2000 was first approved in 2007 for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection. It is stockpiled both in the U.S. and internationally as the primary smallpox vaccine for bioterrorism. Central Africa has seen an outbreak of a concerning mpox variant (cladeIb) that led the World Health Organization to declare a public health emergency of international concern on Aug. 14, 2024. This variant is known to cause more severe infections and a higher mortality rate. Human and animal studies showed ACAM2000 to be effective in protecting against mpox virus exposure. ACAM2000 is administered through a bifurcated, or two-pronged, needle in the upper arm percutaneously. The upper arm skin is pricked several times after being dipped into the vaccine solution. Individuals with severe immunodeficiency should not receive ACAM2000 as they are not expected to benefit from the vaccine. The labeling for ACAM2000 contains a boxed warning due to several potential safety concerns including inflammation in and around the heart and brain. For full prescribing details, click here.