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UPLYSO(TM) (alfataliglicerase) Approved in Brazil by ANVISA for the Treatment of Gaucher Disease
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Mar
18
UPLYSO is known as ELELYSO™ (taliglucerase alfa) outside of
"ANVISA's approval of UPLYSO demonstrates Pfizer's ability to successfully bring therapies for rare diseases to the marketplace," said UPLYSO is the first plant cell-based ERT for the treatment of Gaucher disease. It is also the first approved plant cell-expressed drug that is derived from ProCellEx®, Protalix's proprietary plant cell-based protein manufacturing system, using genetically engineered carrot cells. UPLYSO is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease.
"The approval of UPLYSO provides an important treatment option for those in
On
Indication for UPLYSO in UPLYSO (alfataliglicerase) is indicated for long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease. The manifestations of Gaucher disease may include one or more of the following: splenomegaly, hepatomegaly, anemia, thrombocytopenia, bone disease.
Important Safety Information for UPLYSO in As with any intravenous protein medicine, like enzyme replacement therapy (ERT), UPLYSO may cause infusion-related reactions (i.e., occurring during or shortly after infusion) and hypersensitivity reactions. If a severe allergic reaction occurs, immediate discontinuation of the alfataliglicerase infusion is recommended. Patients who experience reactions of hypersensitivity or related to the infusion, can however be managed successfully. The therapy can be continued by slowing the infusion rate, treating with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with decreased infusion rate. Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions. The most commonly observed infusion reactions were headache, hypersensitivity (allergic reaction), dizziness, flushing (redness), throat irritation, nausea (qualm), pruritus (itch), erythema (redness), rash, bone pain, back pain, arthralgia (joint pain), among others. Also, there is a possibility of developing antibodies to UPLYSO. However, it is currently unclear whether this has an impact on the clinical response or adverse reactions. Patients with an immune response to other ERTs who are switching to UPLYSO should continue to be monitored for antibodies. Patients who have developed infusion or immune reactions with UPLYSO or with another ERT should be monitored for antidrug antibodies when being treated with UPLYSO. If you are pregnant, or plan to become pregnant, you should talk to your doctor about potential benefits and risks. Indication for ELELYSO in the U.S. ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease. Important Safety Information for ELELYSO in the U.S. As with any intravenous protein medicine, like enzyme replacement therapy (ERT), severe allergic reactions (including anaphylaxis) have been observed in patients treated with ELELYSO. If this occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated. Patients who have experienced anaphylaxis to ELELYSO or another ERT should proceed with caution upon retreatment. In addition, infusion reactions (including allergic reactions)—defined as a reaction occurring within 24 hours of the infusion—were the most commonly observed reactions to ELELYSO. The most commonly observed infusion reactions were headache, chest pain or discomfort, weakness, fatigue, hives, abnormal redness of the skin, increased blood pressure, back or joint pain, and flushing. Other infusion or allergic reactions included swelling of the face, mouth, and/or throat; wheezing; shortness of breath; skin color turning blue; coughing; and low blood pressure. Most of these reactions were mild and did not require treatment. Management of infusion reactions is based on the type and severity of the reaction. Your doctor may manage infusion reactions by temporarily stopping the infusion, slowing the infusion rate, or treating with medications such as an antihistamine and/or a fever reducer. Treatment with antihistamines and/or corticosteroids prior to infusion with ELELYSO may prevent these reactions. Other common adverse reactions observed were upper respiratory tract infections, throat infection, flu, urinary tract infection, and pain in extremities. As with all therapeutic proteins, including ERTs, there is a possibility of developing antibodies to ELELYSO. However, it is currently unclear whether this has an impact on the clinical response or adverse reactions. Patients with an immune response to other ERTs who are switching to ELELYSO should continue to be monitored for antibodies. Comparison of the frequency of antibodies across ERTs may be misleading. Patients who have developed infusion or immune reactions with ELELYSO or with another ERT should be monitored for antidrug antibodies when being treated with ELELYSO. If you are pregnant, or plan to become pregnant, you should talk to your doctor about potential benefits and risks. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care provider, considering the unique characteristics of the patient.
This product information is intended only for residents of
You are encouraged to report negative side effects of prescription drugs to the About Gaucher Disease Gaucher disease is an inherited lysosomal storage disorder in humans that affects an estimated 10,000 people worldwide and can cause severe and debilitating symptoms, including: enlargement of the liver and spleen, various forms of bone disease, easy bruising and anemia (a low number of red blood cells). Gaucher disease consists of varying degrees of severity; it has been sub-divided into three subtypes—Types 1, 2 and 3—according to the presence or absence of neurological involvement. Type 1, the most common, is found at a higher frequency among individuals who are of Ashkenazi Jewish ancestry.
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Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based protein expression system, ProCellEx®. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first product manufactured by ProCellEx, ELELYSO™ (taliglucerase alfa), was approved for marketing by the Protalix Forward Looking Statement Disclaimer
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties related to the timing of a commercial launch in
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of
This release contains forward-looking statements about taliglucerase alfa (generic name: alfataliglicerase in
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended CONTACT: Pfizer Contacts: |