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Shire plc SHPG announced that the European Commission has granted an extension of the market authorization for its gastrointestinal drug (GI) Revestive for use in the pediatric population.
Revestive 5 mg powder and solvent has been approved for the treatment of patients aged one year and above with short bowel syndrome (SBS).
An approval was on the cards given that the Committee for Medicinal Products for Human Use (CHMP) had given a positive opinion on the same in May 2016.
We remind investors that Revestive is approved in Europe for the treatment of adult patients with SBS who have become stable following a period of intestinal adaptation post surgery. The drug is also approved in the U.S. as Gattex for injection in adult patients with SBS who are dependent on parenteral support.
The label expansion of Revestive for use in the pediatric population should boost its sales.
We note that Shire has a solid presence in the rare disease markets. The company acquired NPS Pharmaceuticals Inc. in Feb 2015, thereby adding Revestive/Gattex and Natpara (hypoparathyroidism) to its portfolio and providing a major boost to its GI franchise.
We are also encouraged by the company’s efforts to develop its GI franchise. Last month, the company acquired global rights to Pfizer Inc.’s PFE PF-00547659 for the treatment of moderate-to-severe inflammatory bowel disease (IBD). Shire also obtained Breakthrough Therapy Designation from the FDA for two of its GI candidates – SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).
Shire currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector include Abbott Laboratories ABT and Johnson & Johnson JNJ. Both stocks carry a Zacks Rank #2 (Buy).
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