FDA Approves Baxter International, Inc., Halozyme Therapeutics, Inc.'s HYQVIA

Published: Sep 15, 2014

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September 15, 2014

By Jessica Wilson, BioSpace.com Breaking News Staff

Baxter International, Inc. and Halozyme Therapeutics, Inc. today announced that the United States Food and Drug Administration (FDA) approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HyQVia.

This approval marks a reversal from the FDA’s previous rejection of the Deerfield, Ill.-based healthcare company’s HyQ, as it was then known, in 2012. At that time, the FDA requested more pre-clinical data.

Today’s approval was met warmly by the company as a successful second attempt.

“The availability of HyQvia has a significant impact on the treatment of PI, allowing for effective delivery of a full therapeutic dose of IG less frequently than other subcutaneous treatments (up to once a month), while maintaining the efficacy, safety and tolerability profile that is most important for patients,” said Ludwig Hantson, president of Baxter BioScience. “This approval highlights the support of the patient community for new treatment options.”

It is estimated that 250,000 people in the U.S. suffer from PI (primary immunodeficiency) and that this market could be worth at least $1 billion, depending on the pricing of the treatment options.

Baxter expects to launch HyQvia in the U.S. in the coming weeks. HyQvia is currently being prescribed in several European countries, where the treatment achieved approval in 2013 for patients with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections.

People with PI disorders are missing some of their body’s immune defenses, which cause them to be far more susceptible to germs and thus to contract frequent infections.

Currently, most patients with PI receive intravenous infusions in a doctor’s office or infusion center for their treatments. Subcutaneous treatments involve weekly visits with multiple infusion sites per treatment.

HyQvia, on the other hand, which is an immune globulin infusion with recombinant human hyaluronidase, will reduce the number of infusions to one every three to four weeks, with only one injection site per treatment. HyQvia is the first treatment of its kind.

In April 2013, Brian Wilson of BioMed Reports, noted that Baxter had taken over the development of HyQvia, though Halozyme would still receive milestone payments and royalty fees.

San Diego, Calif.-based Halozyme heralded the news as a major step forward in its research and development units.

“Today’s FDA approval of HyQvia is a significant milestone for Halozyme as it represents the first U.S. approved Biologics License Application which utilizes our rHuPH20 platform,” said Helen Torley, president and chief executive officer of Halozyme, in a statement.

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