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news.Pfizer has announced that the Orthodox Union (OU) has granted kosher certification to ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease.
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ELELYSO is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the U.S. Food and Drug Administration (FDA) in May 2012.
"Type 1 Gaucher disease is a rare disease, most frequently found among individuals of Ashkenazi Jewish descent, which has a significant impact on patients and their families," said Rory O’Connor, Pfizer’s Senior Vice President, Head of Global Medical Affairs, Innovative Pharma Business.
"This certification reflects Pfizer’s commitment to all patients suffering from Type 1 Gaucher disease."1
ELELYSO is an FDA-approved plant-based treatment option for Type 1 adult Gaucher patients that,
in addition, meets the stringent standards of kosher regulation and inspections. The OU, the most recognized certifier of kosher products worldwide, inspected the Protalix Biotherapeutics manufacturing facility in Israel in which ELELYSO is produced to ensure that the treatment met all applicable qualifications.
The criteria were met due to Protalix’s innovative and proprietary manufacturing system which uses genetically engineered carrot cells grown in a simple solution of water, plant extracts, sugar, and a mixture of vitamins and minerals to produce ELELYSO.
"We are proud to grant kosher certification to ELELYSO. Gaucher disease and its treatment options are an important issue in the Jewish community, as one in 14 Ashkenazi Jews are carriers for the disease compared to the general population,"2 said Rabbi Menachem Genack, CEO of OU Kosher.
"In a life or death situation, Jewish law clearly sets aside the kosher status of a prescription medicine, but in other cases, it is preferable and sometimes recommended that a medicine be certified kosher. We commend Pfizer for taking this step and making this commitment to the Jewish community."
Protalix is the first Israeli biotech firm to partner with Pfizer Inc. ELELYSO is the first FDA-approved plant cell-based recombinant therapeutic protein.
"Protalix has a close connection and deep understanding of the Gaucher community," said Shomrat Shurtz, Senior Director of lysosomal therapeutics products, Protalix. "This is yet another example to the strong commitment from both Pfizer and Protalix to Gaucher patients."