United Therapeutics Corporation’s UTHR cancer drug, Unituxin, gained FDA approval for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 and 13-cis-retinoic acid for the treatment of pediatric patients suffering from high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
This makes Unituxin the first therapy to be approved by the FDA for this indication.
With the approval, the FDA also issued a rare pediatric priority review voucher (PPRV) for neuroblastoma. The voucher can be used to obtain priority review for a new drug application or biologics license application submitted later. As an added advantage, United Therapeutics might sell or transfer the voucher in the future.
However, Unituxin’s approval in the U.S. comes with a boxed warning stating it can cause severe life threatening infusion reactions. Moreover, the company will be required to conduct certain post-marketing studies.
We are pleased with the FDA issuing a PPRV. This would encourage the development of drugs to treat rare pediatric diseases. According to the press release issued by the company, neuroblastoma, a rare pediatric disease, is estimated to affect approximately 700 patients in the U.S. annually, half of whom fall in the high-risk category.
We note that Unituxin is currently under review in the EU for the same indication. Unituxin enjoys orphan drug status both in the U.S. and EU.
United Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Lannett Company, Inc. LCI, Salix Pharmaceuticals Ltd. SLXP and Astellas Pharma, Inc. ALPMY. While Lannett and Salix hold a Zacks Rank #1 (Strong Buy), Astellas is a Zacks Rank #2 (Buy) stock.
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