The Food and Drug Administration has put forward an additional request before Baxter International Inc. and Halozyme Therapeutics Inc to provide more information related to the long term use of their immune disease drug HyQ. This move would affect the shares of the company which has been trying very hard to get their product approved by the regulator.
According to the company, the drug allows the physicians to alter the therapy accordingly depending on the lifestyle and medical needs of patients with the immune system disorders. It uses a combination of immune globulin and recombinant human hyaluronidase.
The company was hopeful that they would be able to start selling their treatment in the first half of 2012, but constant delays in approval by the regulator has ensured that it might not come in to the market until 2013 or even later.
Although there won’t be any big financial implication on the projection of the company for the year 2012, it surely would affect the sentiments of the company which has been trying really hard to get the approval. It is estimated that Baxter International Inc would lose nearly $90 million in revenue in 2013 due to this delay.