2012Medicine
The US approves Elelyso, a Gaucher disease treatment made in carrot cells by Israel's Protalix.
The FDA approves the injection on 1 May 2012, 15 months after first rejecting the application because it needed more data.
The story in numbers.
Here is how it happened.
30 November 2009
Protalix and Pfizer sign a deal to develop the drug.
The agreement covers taliglucerase alfa, the substance in Elelyso. Supply problems with other enzyme treatments have affected Gaucher patients in several countries since 2009.
SourceProtalix
Before the first FDA review
Two studies test the drug in adults with type 1 Gaucher disease.
One randomized, double-blind study follows 31 adults not yet treated with enzyme therapy for nine months. A second study switches 25 patients from imiglucerase.
SourceProtalix
Early 2011
The FDA first rejects the application.
It asks for more data. The approval comes 15 months later.
SourceGlobes
Carrots, the plant whose cells the drug is made in. File photo by Stephen Ausmus, public domain, via Wikimedia Commons.
1 May 2012
The FDA approves Elelyso, made in genetically engineered carrot cells.
It is a long-term enzyme replacement therapy for adults with type 1 Gaucher disease, given by injection every other week. The company calls it the first FDA-approved plant-cell-based therapy of its kind for the disease.
SourceUS FDA
1 of 4
Here is why it matters.
In Gaucher disease the body does not have enough of an enzyme, so fatty materials collect in organs such as the spleen and liver. Elelyso replaces the missing enzyme.
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2006
Technion-developed Azilect, a Parkinson's drug, wins US approval.
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Prof. Ruth Arnon, a co-developer of Copaxone. File photo by Weizmann Institute of Science, public domain, via Wikimedia Commons.
1996
Weizmann Institute's multiple sclerosis drug Copaxone wins US approval.
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A swallowable camera capsule. File photo by Euchiasmus, public domain, via Wikimedia Commons.
2001
Israel's Given Imaging gets US permission to sell a swallowable camera.
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Where each fact was read.
Sources read on 1 November 2026.