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The Medicines Co.'s 3 Acute Care Drugs Approved in EU - Analyst Blog

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The Medicines CompanyMDCO announced that the European Commission (EC) has cleared three of the company's hospital acute care products - Kengrexal (cangrelor), Orbactiv (oritavancin) and Raplixa (sealant powder).

The approvals did not come as a surprise as earlier this year, the European Medicines Agency's Committee for Medicinal Products for Human Use had issued positive opinions regarding the marketing authorization for Orbactiv, Raplixa and Kengrexal.

Kengrexal is the first and only immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI. A new drug application for Kengreal is under FDA review.

Orbactiv, an intravenous antibiotic, will address acute bacterial skin and skin structure infections caused by susceptible isolates of Gram-positive microorganisms, including Methicillin-resistant Staphylococcus aureus. We note that Orbactiv is already approved in the U.S.

Raplixa is a ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a wide range of bleeding settings. A biologics license application for Raplixa is under FDA review. The company expects this product to be well received by the surgical community.

We are pleased with the EC approval for Orbactiv, Raplixa and Kengrexal. We expect investor focus to remain on regulatory updates from the company.

The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Affymetrix Inc. AFFX , Cytokinetics, Incorporated CYTK and Lannett Company, Inc. LCI . All three sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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