FDA Extends Review of Rocket Pharma's Proposed Kresladi

By Colin Kellaher

Rocket Pharmaceuticals on Tuesday said the U.S. Food and Drug Administration has extended its review of the biotechnology company's application seeking approval of its proposed treatment of a rare pediatric immunodeficiency disorder.

Rocket said the FDA extended its target action date for a decision on marnetegragene autotemcel in severe leukocyte adhesion deficiency-I to June 30 from March 31 after the Cranbury, N.J., company submitted clarifying chemistry, manufacturing and controls) information in response to requests from the agency.

Rocket said the FDA confirmed that it won't hold an advisory committee meeting on the application for marnetegragene autotemcel, which the company plans to market as Kresladi.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

02-13-24 0741ET