Shire's Immunodeficiency Treatment Cuvitru Gets FDA Approval

Shire plc (NASDAQ:SHPG) announced that the FDA has granted approval for Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution) for the treatment of adult and pediatric patients with primary immunodeficiency (PI).

Note that PI affects six million people globally and comprises 300 genetic disorders, in which a portion of the body's immune system stops functioning or functions improperly.

Shire expects to launch Cuvitru in the U.S. in the upcoming weeks. We remind investors that Cuvitru was approved in 17 European countries in Jun 2016. The company expects to initiate additional global regulatory submissions in late 2016 and 2017.

The approval of Cuvitru will broaden Shire’s intravenous and subcutaneous immunolglobulin (IG) product portfolio.

Shire holds a strong position in the attention deficit hyperactivity disorder (ADHD) market with drugs like Vyvanse and Intuniv. The company is making efforts to venture into the ophthalmology and gastrointestinal markets as well.

The company received a major boost when the FDA approved its ophthalmology drug Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution for the treatment of the signs and symptoms of dry eye disease (DED) in adults. This approval will enable the company to build a strong ophthalmology franchise.

Meanwhile, the Feb 2015 NPS Pharma acquisition added Gattex/Revestive (short bowel syndrome) and Natpara/Natpar (an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism) to Shire’s gastrointestinal portfolio.

Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Ligand Pharmaceuticals (NASDAQ:LGND) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Pacira Pharmaceuticals (NASDAQ:PCRX) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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