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Baxter - Halozyme’s HyQ faces delay after FDA data request

Anticipated delay in immune disorder treatment’s approval causes US healthcare company’s shares to drop

The US Food and Drug Administration (FDA) has asked Baxter and Halozyme to provide more information to support their biological licence application (BLA) for the immune disorder treatment HyQ.

Baxter acknowledged this would delay the drug's regulatory review and shares of the US healthcare company dropped 7 per cent following the announcement.

The US regulator raised concerns over the range of data available involving the long-term chronic use of the therapy, which is being developed to treat primary immunodeficiencies.

Primary immunodeficiencies are inherited conditions that occur when part of a person's immune system is missing or works incorrectly. People living with such conditions cannot get rid of germs or protect themselves from new germs in an efficient manner.

Baxter had already released data at the 2012 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual meeting in Orlando to support the long-term use of HyQ.

It is unclear whether the company will be able to use data from a longer-term follow-up of this original trial, or whether a new study will have to be implemented.

Baxter and Halozyme said they will work together to develop further studies to provide the FDA with more information, including a meeting with the agency's Blood Products Advisory Committee to determine what data is required.

HyQ, which is intended to be marketed as HyQvia if approved, is a combination product comprising immune globulin (IG) and recombinant human hyaluronidase.

The therapeutic effect of the treatment is provided by IG, while recombinant human hyaluronidase causes the drug to spread through the body. The hyaluronidase technology is developed through Halozyme's platform, which has been licensed by Baxter.

17th April 2012

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