The FDA approved a supplemental biologics license application for Asceniv, expanding its use to younger patients with primary humoral immunodeficiency, according to a press release.
Prior to this approval, the release noted that the prescribing information for Asceniv (ADMA Biologics), a plasma-derived, polyclonal, intravenous immunoglobulin therapy, said it was only available for patients with primary humoral immunodeficiency aged at least 12 years. Now, it is available for patients aged at least 2 years.
Asceniv is now available for use in patients with primary humoral immunodeficiency aged at least 2 years, according to a press release.
Asceniv first received FDA approval in April 2019, according to the release.
Kelli Williams
“Respiratory viruses, especially RSV, have significant impact on our pediatric patients, particularly those with primary immunodeficiency (PI),” Kelli Williams, MD, MPH, section chief of pediatric allergy at Medical University of South Carolina, said in an email statement. “This often leads to ER visits, hospitalizations, missed school days and missed workdays for parents.
“This new pediatric indication for Asceniv is exciting as it will offer a new treatment option for kids with PI that may improve their quality of life,” she said.
Sources/Disclosures
Source:
Press Release
Disclosures:
Williams reports receiving research/clinical trial support from ADMA Biologics, AstraZeneca, Cogent Biosciences, GlaxoSmithKline and Pharming Healthcare; being a consultant/on advisory boards/steering committees for ADMA Biologics, Amgen and Pharming Healthcare; and serving on a speakers bureau for Amgen and Pharming Healthcare.
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