The rejection is not due to the therapy’s formulation, safety or efficacy, according to the drugmaker. Instead, the FDA’s response “is related to observations as part of a standard pre-approval inspection at a manufacturing facility,” J&J said in a Dec. 16 statement.
Rybrevant (amivantamab) is currently approved in an intravenous presentation. The experimental injection drug combines amivantamab and recombinant human hyaluronidase.
J&J said it is working with the FDA to bring the formulation to market.
