AbbVie's ABT-414 Gets Rare Pediatric Disease Status In U.S.

AbbVie Inc. (NYSE:ABBV) announced that its oncology candidate, ABT-414, has been granted Rare Pediatric Disease Designation in the U.S. for the treatment of pediatric patients with epidermal growth factor receptor (EGFR)-amplified diffuse intrinsic pontine glioma (DIPG) – highly aggressive and difficult-to-treat brain tumors found at the base of the brain.

The designation was granted based on a proposed pediatric sub-study ‘nested’ within the ongoing phase II study on ABT-414 in adults with recurrent EGFR-amplified glioblastoma that is being conducted in collaboration with the European Organization for Research and Treatment of Cancer.

In 2014, ABT-414 received Orphan Drug Designation in both the U.S. and the EU for the treatment of adult glioblastoma and glioma, respectively.

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We note that AbbVie is developing ABT-414 with certain components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics (NASDAQ:SGEN) .

According to the press release issued by AbbVie, brainstem tumors comprise approximately 10–15% of all pediatric brain tumors. Each year, approximately 200–400 children are affected by DIPG in the U.S.

Given the limited options for the treatment of glioblastoma and glioma, there is urgent need for new treatments in this field. If successfully developed and commercialized, ABT-414 will be able to boost the company’s portfolio.

Currently available drugs for the treatment of glioblastoma include Avastin, Tamodar and Gliadel.

AbbVie currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include GW Pharmaceuticals plc (NASDAQ:GWPH) and Innoviva, Inc. (NASDAQ:INVA) . Both stocks sport a Zacks Rank #1 (Strong Buy).

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