Anifrolumab (Saphnelo) Gets Green Light for Approval in EU

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for anifrolumab (Saphnelo) as an add-on treatment for adults with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy, according to an announcement on Dec. 16.

Anifrolumab, a monoclonal antibody that binds to subunit 1 of the type I interferon receptor and thereby blocks the biologic activity of type I interferons, was approved by the US Food and Drug Administration in July 2021.

The recommendation for anifrolumab is based on its ability to elicit a clinical response on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52, which is defined as improvement in all organ domains with moderate or severe SLE activity at baseline.

The manufacturer AstraZeneca said the biologic drug will be available as a 300 mg concentrate for solution for infusion.

The most common adverse reactions are upper respiratory tract infection, bronchitis, infusion-related reaction, and herpes zoster. The most common serious adverse reaction was herpes zoster.

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

Note: This article have been indexed to our site. We do not claim legitimacy, ownership or copyright of any of the content above. To see the article at original source Click Here

Alpha Grillers Instant Read Meat Thermometer for Grill and Cooking. Best Waterproof Ultra Fast Thermometer with Backlight & Calibration. Digital Food Probe for Kitchen, Outdoor Grilling and BBQ!

(68080)

$15.99 (as of June 30, 2024 21:12 GMT +00:00 - More infoProduct prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on [relevant Amazon Site(s), as applicable] at the time of purchase will apply to the purchase of this product.)

iPhone Car Charger Fast Charging [Apple MFi Certified], 60W Dual USB-C Power Cigarette Lighter Car Charger+Type-C Cable&Lightning Cable for iPhone 15 14 13 12 11 Pro Plus XS XR iPad, Samsung and More

(61)

$9.99 (as of June 30, 2024 21:12 GMT +00:00 - More infoProduct prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on [relevant Amazon Site(s), as applicable] at the time of purchase will apply to the purchase of this product.)

Super Mario Bros.™ Wonder - Nintendo Switch (US Version)

(7450)

$51.93 (as of June 30, 2024 21:12 GMT +00:00 - More infoProduct prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on [relevant Amazon Site(s), as applicable] at the time of purchase will apply to the purchase of this product.)

Misxi 2 Pack Hard PC Case with Tempered Glass Screen Protector Compatible with Apple Watch Series 9 (2023) Series 8 Series 7 45mm, Ultra-Thin Scratch Resistant Cover for iWatch S9/S8/S7, Black

(156749)

$9.96 (as of June 30, 2024 21:12 GMT +00:00 - More infoProduct prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on [relevant Amazon Site(s), as applicable] at the time of purchase will apply to the purchase of this product.)

Nespresso Capsules VertuoLine, Variety Pack, Medium and Dark Roast Coffee, 30 Count Coffee Pods, Brews 7.8 oz

(60954)

$37.50 (as of June 30, 2024 21:12 GMT +00:00 - More infoProduct prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on [relevant Amazon Site(s), as applicable] at the time of purchase will apply to the purchase of this product.)