By Lauren Pollock
Baxter International Inc. (BAX) said it received another request
for additional information from the U.S. Food and Drug
Administration related to its investigational product HyQ, which is
in development with Halozyme Therapeutics Inc. (HALO), following a
similar letter in April.
The FDA's request delays any potential approval of HyQ, a
treatment that aims to allow physicians to tailor antibody drug
therapy to the lifestyle and medical needs of patients with
immune-system disorders.
Halozyme shares plunged 50% to $4.25 after hours, while Baxter
was unchanged at $58.63.
The FDA's latest letter seeks additional preclinical data to
support the application. The primary issues raised in the letter
focus on non-neutralizing antibodies generated against recombinant
human hyaluronidase and the possible effects of these antibodies on
reproduction, development and fertility.
HyQ, which is based on a Baxter IV drug, targets a condition
called primary immunodeficiency, which can involve any of more than
150 diseases that cause the immune system to function poorly or not
at all. At least 250,000 Americans have the condition, many of them
children.
HyQ is infused under the skin but, like intravenous treatments,
appears to only need infusions every three or four weeks.
Baxter said it plans to file an amendment to the application for
HyQ following additional talks with the FDA. Patients enrolled in
ongoing HyQ studies will now be treated with Baxter's immune
globulin therapy without recombinant human hyaluronidase, at the
FDA's request.
The prior request had to do with chronic long-term data on an
ingredient in the drug.
Write to Lauren Pollock at lauren.pollock@dowjones.com
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