Johnson & Johnson Seeks EU and US Label Expansion for Darzalex




Johnson & Johnson’s (JNJ) subsidiary Janssen Pharmaceuticals filed regulatory submissions for label expansion of its multiple myeloma drug Darzalex (daratumumab) in the United States and the European Union in early August. The company is seeking approval for a split dosing regimen for Darzalex that will provide an option of splitting the first infusion of Darzalex over two consecutive days, which is expected to improve the medication’s administration profile.

JNJ submitted a supplemental Biologics License Application to the FDA and a Type II Variation to the EMA (European Medicines Agency). If they are approved, JNJ stock could likely get a boost on positive market sentiment.

JNJ has witnessed a strong growth momentum in Darzalex sales over the past quarters and expects the expansion in indications to further accelerate sales going forward.

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Multiple indications approved for Darzalex would target a wide market

Janssen Pharmaceuticals obtained the license to develop and commercialize Darzalex in 2012 when it entered into an agreement with Genmab A/S. Darzalex is approved for five indications for the treatment of multiple myeloma. In the United States, the drug first received approval in November 2015. It was approved in the European Union in May 2016. Darzalex registered sales of $1.24 billion in 2017.

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