FDA clears The Medicines Company's Raplixa, Ionsys

The FDA approved The Medicines Company's Raplixa (fibrin sealant) as the first spray-dried fibrin sealant cleared in the US to help control bleeding during surgery, the company announced. The biological product is approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques are ineffective or impractical.

According to the FDA, Raplixa can be applied directly from the original product vial or by spraying with the RaplixaSpray device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge. "This approval provides surgeons an additional option to help control bleeding during surgery when needed," commented Karen Midthun, director of the agency's Center for Biologics Evaluation and Research.

In its assessment of Raplixa, the FDA reviewed data from a Phase III study involving 719 participants, over 11 months, undergoing different types of surgical procedures. The regulator noted that the trial demonstrated Raplixa's effectiveness by comparing the reduction in the time needed for bleeding to stop when using the fibrin sealant and the time needed for bleeding to stop when using an absorbable sponge alone.

In addition, the FDA approved The Medicines Company's Ionsys for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital. The drugmaker noted that Ionsys, which will be launched in the third quarter, is the first needle-free, patient-controlled, pre-programmed fentanyl delivery system.

The approvals come as The Medicines Company faces a drop in sales of its anticoagulant Angiomax (bivalirudin), which accounted for over 80 percent of revenue last year. Earlier this year, the company said it expects lower first-quarter sales, with revenue from Angiomax in the range of $97 million to $105 million, versus $155.7 million in the same period of 2014, due to potential generic competition.

Commenting on the news, RBC Capital analyst Adnan Butt said any drug approval for the company "would be considered positive at this time." Butt estimates that Raplixa will generate peak sales of about $100 million in the US, while global revenue from Ionsys could reach $500 million in 2022. The Medicines Company gained Ionsys via its 2012 acquisition of Incline Therapeutics, with the product awaiting a regulatory decision in Europe.

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