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NAPSR News: FDA Approves Genzyme’s Cerdelga™ (eliglustat) Capsules to Treat Gaucher
Cerdelga™ is the only first-line oral therapy approved to treat adults with Type 1 Gaucher Disease, a rare genetic disorder that affects specific cells and organs in the body.
“Cerdelga is an important new option for people living with Gaucher disease type 1,” said Rhonda Buyers, CEO of the National Gaucher Foundation. “As enzyme replacement therapy is the standard of treatment for Gaucher disease, patients receive regular intravenous infusions for life. With FDA's approval of a first-line oral treatment, Cerdelga has the potential to be a valuable treatment option for people living with this serious disease.”
“The approval of Cerdelga is encouraging for Gaucher patients because it is a first-line oral treatment that has demonstrated a positive risk/benefit profile, making it important from both a scientific and a clinical perspective,”
FDA approval stems from clinical data achieved from two Phase 3 studies evaluating the drug’s safety and efficacy. Trial 1 was conducted involving 40 participants who had not previously received enzyme replacement therapy. Patients showed significant progress after 9 months. Reduction in spleen volume was observed, liver volume, blood platelet count, and red blood cell (hemoglobin)
Trial 2 involved 159 patients previously treated and stabilized on enzyme replacement therapy. The results obtained were of clinical significance as spleen volume, hemoglobin levels, platelet counts, and liver volume were stabilized.
Gaucher is a rare inherited disease affecting fewer than 10,000 people worldwide. In patients affected, they do not have enough of an enzyme, β-glucosidase (glucocerebrosidase)
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CANDIDATES WHO WANT TO BREAK INTO PHARMACEUTICAL SALES!
The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community.
The CNPR® Program represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Pharmaceutical sales candidates who have this training will differentiate themselves from other individuals looking for open positions. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. CNPR® graduates should immediately utilize the NAPSRx® Career Center to apply for pharmaceutical sales positions.
Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(