J&J: Janssen submits subcutaneous drug for European approval

(CercleFinance.com) - Janssen has submitted a new formulation of its multiple myeloma drug, Darzalex, for approval in Europe, the J&J unit said on Friday.


The company today announced the submission of an extension application to the European Medicines Agency (EMA) for subcutaneous use (under the skin) for the treatment of patients with multiple myeloma.

Darzalex is currently only approved for intravenous use.

According to Janssen, data showed that the investigational subcutaneous formulation was non-inferior compared to intravenous administration.

Janssen has also submitted a file to the U.S. Food and Drug Administration (FDA) seeking approval of the new subcutaneous formulation.

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