FDA Approves ADMA's Asceniv for Pediatric Use

By Chris Stiles • Monday, May 04 12:02 • Permanent Link

ADMA Biologics said the FDA has approved an expanded label for Asceniv, allowing the immune globulin treatment to be used in pediatric patients with primary humoral immunodeficiency who are 2 years old and older. Before the change, the drug’s label covered patients 12 years and older.

The approval follows ADMA’s supplemental biologics license application and completes the final study report for the pediatric assessment required under the post-marketing commitment.

Asceniv was first approved in April 2019. With the new label expansion, ADMA now has an FDA-approved option for a younger patient group that was previously excluded from the product’s indicated use.

The company’s commercial portfolio includes three FDA-approved plasma-derived biologics: Asceniv, Bivigam and Nabi-HB. ADMA also continues development work on SG-001, a pre-clinical hyperimmune globulin targeting S. pneumonia. Today the company's shares have moved 1.62% to a price of $11.26. Check out the company's full 8-K submission here.

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