Pfizer Inc. today 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 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.”
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 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.”
For more information about Gaucher disease, please visit www.ELELYSO.com. [TLS]
there is no reason for medication to need a hashgacha and this sets a terrible precedent
Sure there is a reason. It is ‘Metamtem es Halev’ if it is not kosher. You may be required by halacha to take it anyway… but the Shulchan Aruch says it still has that effect. One has to be careful to set that aside when the medicine needs to be taken… but if given the choice between kosher and not… so long as they both accomplish what is needed… you take the kosher. The certification can drive a certain set of the population and will be an incentive for manufacturers to offer it. Very often it can be prepared equally in various different methods. If this brings some companies to prepare an equally effective medication in a way that is kosher… then it is great.
I thought only liquid medication had an issue with kashrus. Do you have a source/psak that says an “injection” is also b’tamtem es halev.
I don’t say this to be critical I’d really like to know.
My comment was mainly on the statement “no reason for medication to need a hashgacha”. I was also a little surprised seeing as it was an injection. I do know this is talked about… and it also includes using non-kosher anumal parts for things like heart valves and gene therapy (its own conversation). I am not knoweldgable enough on all that to really comment. My point was just on the blanket statement about medication and kashrus. Sorry. ;-(
Medicines of ANY type do not need a hashgacha. Period. No timtum halev involved. Its not rauoy leachila. Its not food. Can it be any simpler that that. This is not bringing mashiach, its pushing him away. When klal yisroel is focusing on this narishkeit instead of really pertinent issues the satan has won. We have taken our eyes off the proverbial ball.