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Shire (SHPG) HAE Drug Gets FDA Nod for Pediatric Population

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Shire plc (SHPG - Free Report) announced that the FDA has approved the label expansion of its hereditary angioedema (HAE) drug, Cinryze, to use in children aged six years and above.

Cinryze has been approved in the United States since October 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE,a rare genetic disorder causing painful swelling on various parts of the body. With this latest nod, Cinryze can now be prescribed to prevent angioedema attacks in six-year-old children, making it the first FDA approved treatment option for such a young patient population.

The approval was based on encouraging data from a phase III multicenter single-blind study, which evaluated two doses (500 U and 1000 U) of Cinryze in 12 patients living with HAE, belonging to the 7-11 years’ age bracket. Outcomes from the trial showed that both doses lessened the severity of attacks and reduced the use of acute treatment compared with the baseline.

We remind investors that in the EU, Cinryze is already approved to prevent attacks in the pediatric HAE patient population, per approval received in March 2017.

Shire’s immunology franchise, comprising sales of hereditary angioedema (HAE) drugs, registered sales of $1.13 billion in the first quarter of 2018. The company added Cinryze to its immunology portfolio following the 2015 acquisition of ViroPharma.

Shire is on the verge of a buyout by Japan’s Takeda Pharmaceutical at a proposed value of $62 billion. The deal is expected to close during the first half of next year. The deal was announced in May.

Shares of Shire have increased 3.2% year to date compared with the industry’s rise of 5.4%.


Shire currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include AcelRx Pharmaceuticals, Inc (ACRX - Free Report) , Catalent, Inc (CTLT - Free Report) and BioLineRx Ltd (BLRX - Free Report) , all holding a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

AcelRx Pharmaceuticals’ loss per share estimates has been narrowed by 15.3% for 2018 and 19% for 2019 in the last 60 days. The stock has skyrocketed 102.5% year to date.

Catalent’s earnings estimates have been revised 1.2% upward for 2018 and 1.1% for 2019 in the past 60 days.

BioLineRx’s loss per share estimates has been narrowed by 16.1% for 2018 and 15% for 2019 in the last 60 days

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