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RHONE-POULENC RORER’s LOVENOX (ENOXAPARIN) WILL LAUNCH APRIL 13

Executive Summary

RHONE-POULENC RORER's LOVENOX (ENOXAPARIN) WILL LAUNCH APRIL 13 following FDA approval of the low molecular weight heparin on March 29. Lovenox (enoxaparin sodium 30 mg/0.3 ml) is indicated as an injectable treatment for the "prevention of deep vein thrombosis, which may lead to pulmonary embolism, following hip replacement surgery," labeling states. The Rhone-Poulenc product has been marketed overseas since 1987 as Clexane/Lovenox. It is sold in more than 20 countries and was recently approved in Canada. Sales in 1992 rose 33% to $127 mil. Lovenox was classified by FDA as a "1P" drug, signifying a new molecular entity given a priority review by the agency. Rhone- Poulenc Rorer submitted the original NDA for the anticoagulant in July 1991 and resubmitted a reformatted application (NDA 20-164) on Dec. 30, 1991. Lovenox was deemed "approvable" by the agency last Nov. 20. The approval was based on two clinical trials. In one trial of 100 patients, half of whom received placebo and the other half Lovenox for 10-14 days post-operatively, researchers found a 10% incidence of total deep vein thrombosis (DVT) with Lovenox compared to 46% with placebo and 2% proximal DVT with enoxaparin compared to 22% among placebo patients. The second clinical trial, a double-blind, multicenter dosing regimen study, looked at Lovenox at 10 mg q.d., 30 mg every 12 hours and 40 mg q.d. The approved dosage is a 30 mg injection twice daily, "with the initial dose given as soon as possible after surgery but no more than 24 hours post-operatively," labeling states. The average duration of administration is seven to 10 days, labeling notes. Major bleeding events in patients receiving Lovenox injections were 4% in clinical trials compared to 6% for heparin and 4% for placebo, labeling states. Moderate thrombocytopenia was reported in 2% of Lovenox patients and 3% of heparin patients. Other adverse effects thought to be associated with Lovenox injections and reported at a 2% or greater level during clinical trials included hemorrhage (5%), fever (4%), nausea, hypochromic anemia, edema and peripheral edema (3% apiece) and pain, ecchymosis and confusion (2% each), labeling notes. RPR will be the first company to the market in the U.S. with a low molecular weight heparin product and has been promoting the drug through "coming soon" notices at medical society meetings, including the American Society of Hospital Pharmacists mid-year meeting last December. The company apparently will emphasize the potential cost-savings from use of the drug with the prevention of DVT and pulmonary embolism. Other companies with an NDA pending for a low molecular weight heparin or preparing to file an application include Wyeth-Ayerst (Normiflo), Novo Nordisk (logiparin), Kabi Pharmacia (dalteparin) and Organon (ORG 10172). Lovenox will be available in packs of 10 prefilled syringes. Each 30 mg dose has an anti-Factor Xa activity of approximately 3,000 IUs.
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