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. ELELYSO is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the 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.
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," 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. ELELYSO is the first FDA-approved plant cell-based recombinant therapeutic protein.