August RX Product News

Adalimumab-aaty (Yuflyma)

From: Celltrion USA

The FDA has approved adalimumab-aaty (Yuflyma), which is a high concentration, citrate-free biosimilar of adalimumab (Humira). The 100 mg/mL strength was approved for 8 conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. The approval comes after comprehensive data were submitted to the FDA, including analytics, preclinical data, and clinical studies, showing that the biosimilar is comparable to the reference product in efficacy, safety, pharmacokinetics, and immunogenicity for up to 24 weeks and 1 year after treatment. The most common adverse effects include upper respiratory infection, sinusitis, injection site reaction, headache, and rash.

FOR MORE INFORMATION: celltrionhealthcare.com

A doctor's prescription | Image credit: Goodmanphoto - stock.adobe.com

Milvexian

From: Janssen Pharmaceuticals, Inc, and Bristol Myers Squibb

The FDA has granted fast-track designation to 3 prospective indications for milvexian, which is an oral factor XIa inhibitor. The indications include stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack, recent acute coronary syndrome, and atrial fibrillation. Data to support the designation come from the phase 3 Librexia development program, including the LIBREXIA-STROK (NCT05702034), LIBREXIAACS

(NCT05754957), and LIBREXIA-AF (NCT05757869) trials. Additionally, 2 phase 2 trials—AXIOMATIC-TKR (NCT03891524) and AXIOMATIC-SSP (NCT03766581)— demonstrated a differentiated antithrombotic profile for the drug as both a monotherapy and in combination with antiplatelet therapy. Milvexian has not been approved in any country for any indication.

FOR MORE INFORMATION: janssen.com

Nirmatrelvir and Ritonavir Tablets (Paxlovid)

From: Pfizer Inc

The FDA has approved copackaged nirmatrelvir and ritonavir tablets (Paxlovid) for the treatment of mild to moderate COVID-19 in adults at high risk for disease progression to severe COVID-19, including hospitalization or death. The tablets will continue to be distributed by the US Department of Health and Human Services to increase access for adults and treat eligible children aged 12 to 18 years who are not covered by the full approval. The efficacy was supported by final results of the EPIC-HR trial (NCT04960202), which showed that the tablets reduced the proportion of individuals with COVID-19–related hospitalizations or death from any cause through 28 days of follow-up by 86% vs placebo among those treated within 5 days of symptom onset who did not receive a COVID-19 therapeutic monoclonal antibody treatment.

FOR MORE INFORMATION: pfizer.com

Respiratory Syncytial Virus Vaccine (Abrysvo)

From: Pfizer Inc

The FDA has approved the first respiratory syncytial virus (RSV) vaccine (Abrysvo) to prevent lower respiratory tract disease caused by RSV in individuals 60 years and older. The approval was based on findings from the RENOIR trial (NCT05035212), showing that the vaccine demonstrated 66.7% efficacy against RSV-associated lower respiratory tract illness, which was defined as illness with 2 or more symptoms. For more severe disease (≥ 3 symptoms), the vaccine showed 85.7% efficacy. The trial demonstrated that the vaccine was well tolerated with no safety concerns.

FOR MORE INFORMATION: pfizer.com