Date: 2012-02-03
Type of information: Granting of a Market Authorisation in the US
Product name: Erwinaze®
Compound: asparaginase Erwinia chrysanthemi
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: Asparagine is essential for cell growth. Neoplastic cells associated with ALL are lacking asparagine synthetase activity and rely on asparagine circulating in the blood for growth. L-Asparaginase lowers circulating asparagine levels in the blood thereby depriving the mutated blood cells of asparagine and inhibiting their growth producing anti-neoplastic effect.
Company: EUSA Pharma (USA) now Jazz Pharmaceuticals (USA)
Disease: treatment of patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.
Latest news: * On November 18, 2011, the FDA approved Erwinaze® (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL. Erwinaze® is injected directly into the muscle three times a week and works by breaking down asparagine that is present in the blood, and is necessary for the growth of all cells. Leukemia cells cannot produce this protein building block. When a patient is treated with Erwinaze® the leukemia cells die. Normal human cells are able to make enough asparagine for their own needs through biosynthesis and will not be affected by treatment with Erwinaze®. The safety and effectiveness of Erwinaze® was evaluated in one clinical trial of 58 patients. Additional safety data was collected from the Erwinaze Master Treatment Protocol (EMTP), an expanded access program that enrolled 843 patients. Patients in both studies were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions. In the trial to support efficacy, the main outcome was the measurement of the proportion of patients with sustained asparaginase activity levels that correlate with better leukemia control and survival. All evaluable patients were shown to have maintained the pre-specified threshold for asparaginase activity at 48 or 72 hours after dosing. Side effects associated with Erwinaze® treatment include serious allergic reactions (anaphylaxis), inflammation of the pancreas (pancreatitis), high blood levels of liver enzymes (abnormal transaminases and bilirubin), blood clotting, bleeding (hemorrhage), nausea, vomiting and high blood sugar (hyperglycemia). Prior to Erwinaze®’s approval there were two asparagine specific enzyme products – Elspar® (asparaginase injection) and Oncaspar® (pegaspargase) – approved by FDA to treat patients with ALL. Both of these products are E. coli derived.. Erwinaze® is manufactured by EUSA Pharma Inc. of Langhorne, Pa.
Patents:
Submission of marketing authorization application USA : 2010-11-09
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-11-18
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: * On June 12, 2012, Jazz Pharmaceuticals has announced the closing of its acquisition of EUSA Pharma, a privately-held, specialty pharmaceutical company with a commercial presence in the U.S. and EU and a global distribution network.
