J&J (JNJ) Seeks EU Approval For Darzalex's Expanded Use

Johnson & Johnson’s (NYSE:JNJ) Janssen-Cilag International NV announced that it has filed a type II variation application with the European Medicines Agency seeking label expansion for its immunotherapy, Darzalex, in combination with Revlimid (an immmunomodulatory agent) and dexamethasone, or Velcade (a proteasome inhibitor/PI) and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma patients who have received at least one prior therapy.

Darzalex gained conditional approval in the EU in May 2016 for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunotherapy agent and who have demonstrated disease progression on the last therapy.

The EU filing came a week after the submission of a supplemental biologics license application for a label expansion of Darzalex to the FDA. The company is looking to get Darzalex approved in combination with Revlimid and dexamethasone, or Velcade and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

We note that last month, Darzalex was granted Breakthrough Therapy status by the FDA for this indication. This marks the second time that the drug was granted such status in the U.S. This status expedite the process of development and review of drugs that are being evaluated for the treatment of serious or life-threatening diseases, where preliminary clinical evidence indicates that the drug may provide substantial improvement over existing therapies.

We remind investors that Janssen Biotech, Inc. had entered into a worldwide agreement with Genmab A/S GNMSF in Aug 2012, whereby the former was granted an exclusive license to develop, manufacture and commercialize Darzalex. The submission of the application triggered milestone payments of $10 million to Genmab from Janssen.

We note that Amgen Inc.’s (NASDAQ:AMGN) Kyprolis is also approved for the treatment of multiple myeloma.

Johnson & Johnson has a Zacks Rank #3 (Hold). Corcept Therapeutics Inc. (NASDAQ:CORT) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).