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AbbVie Seeks FDA Approval for Imbruvica's Label Expansion

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AbbVie Inc. (ABBV - Free Report) filed a supplemental new drug application (sNDA) to the FDA for Imbruvica. AbbVie is looking to get FDA approval for a fifth indication – the front-line treatment of patients suffering from chronic lymphocytic leukemia (CLL). Approval for this patient population will boost Imbruvica’s sales significantly.

Imbruvica is already approved in the U.S. for the treatment of patients with mantle cell lymphoma or CLL who have received at least one previous therapy and for CLL patients (treatment naïve) with del 17p. It is also approved for the treatment of patients with Waldenstrom's macroglobulinemia.

We remind investors that Imbruvica was added to AbbVie’s portfolio following the Pharmacyclics acquisition in May 2015. AbbVie has a development and commercialization agreement with Johnson & Johnson’s (JNJ - Free Report) Janssen Biotech, Inc. for Imbruvica.

We are encouraged by AbbVie’s efforts to expand Imbruvica’s label further. AbbVie expects Imbruvica peak sales of more than $7 billion and U.S. sales of about $1 billion in 2015. Imbruvica is currently being studied alone and in combination with other treatments for several types of blood cancer. Label expansion would boost the drug’s sales further.

AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Dr. Reddy's Laboratories Ltd. (RDY - Free Report) , Gilead Sciences Inc. (GILD - Free Report) and Johnson & Johnson. While Dr. Reddy's and Gilead are Zacks Rank #1 (Strong Buy) stocks, Johnson & Johnson holds a Zacks Rank #2 (Buy).

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