FDA okays another drug amid Genzyme shortage

fda

An Israel based company, called Protalix Bio Therapeutics Inc., said that the Food and Drug Administration (FDA) has agreed to the treatment protocol for prGCD which is a treatment of Gaucher disease. According to this protocol the physicians and care-providers will be able to administer the drug before it is approved by FDA.

The FDA decided to go ahead with the grant of the protocol after the much publicized shortage of Genzyme Corp.'s Gaucher treatment, Cerezyme. All this shortage is due to a six week closure of one of the company's plants and the shortage is expected to continue till the end of this year.

Genzyme's shortage has come as an opportunity for protalix. Protalix's shares have shot up since this announcement. Meanwhile the Phase III trials are going on for its Gaucher drug. The company expects to submit the drug for FDA's approval by the end of this year.

Another company that benefited from Genzyme's shortage is the British firm, Shire, also making the Gaucher drug. FDA approved a treatment protocol resulting which their drug can also be administered before getting an approval.

Genzyme, owing to shortage is only providing Cerezyme to three patient groups that are considered the most vulnerable. It has blocked the shipping of cerezyme to other patients since Aug 3.

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