FDA Approves Pediatric Use of Protalix Drug

Following the announcement of the most recent FDA approval at the end of last week, shares of Protalix rose by a combined 7.9%.

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Protalix Biotherapeutics has received expanded permission from the U.S. Food and Drug Administration to market its medication for the treatment of Gaucher’s disease, so that it can now be administered not only to adults but also to children. The move by the FDA follows clinical trials with the drug, Elelyso, among youngsters.

Gaucher’s disease is a genetic condition that causes fatty substances to accumulate in certain cells and organs of affected patients. Protalix, which is based in Carmiel, had received approval in 2012 to market Elelyso for use by adult patients in the United States. It is estimated that about 10% of those who have been diagnosed with the disease are children. Other than in Israel and Brazil, where it sells the drug directly, Protalix markets Elelyso around the world in partnership with Pfizer.

The FDA has now also cleared the way for Protalix to provide Elelyso to adult patients who have not tried two other drugs for the treatment of the disease: Cerezyme, which is manufactured by the Sanofi pharmaceutical group and is the market leader in the field; and Vpriv, which is sold by Shire.

Following the announcement of the most recent FDA approval at the end of last week, shares of Protalix rose by a combined 7.9%, giving the company a market valuation of $243 million, after losing half of its value over the past 12 months.