Abbott Abbokinase Relaunches With Limited Indication, Without Bold Warning

Abbott Abbokinase labeling carries the more limited indication of pulmonary embolism following re-approval of the thrombolytic Oct. 10.

Abbokinase (urokinase) was initially approved for pulmonary embolism, catheter clearance and coronary artery thrombosis in 1978. Production was suspended in early 1999 after FDA found manufacturing deficiencies at Abbott and its human kidney cells supplier (¹ (Also see "Abbott Abbokinase "Dear Doctor" Letter Draws Warning From FDA" - Pink Sheet, 29 Mar, 1999.), p. 8).

Abbott limited the sNDA to pulmonary embolism in order to speed Abbokinase's reintroduction. The filing contained a chemistry, manufacturing & controls supplement and changed the source material to U.S.-based tissue. The sNDA was submitted Dec. 31 (² (Also see "Abbott Projects Synthroid Double-Digit Growth Despite Early-2002 Phase-Down" - Pink Sheet, 21 Jan, 2002.), p. 34).

Abbokinase Phase III studies on recombinant urokinase are underway in catheter clearance, and Abbott expects to file in 2003. The firm has no plans to pursue a coronary artery thrombosis indication.

Labeling drops the bolded warning that "thrombolytic therapy should be considered in all situations where the benefits to be achieved outweigh the risk of potentially serious hemorrhage." Abbott added the warning after the GMP issues were identified.

The revised labeling includes warnings from postmarketing reports on infusion reactions - such as anaphylaxis - and cholesterol embolization. Phase IV commitments include an immunogenecity study.

Abbott had hoped to relaunch Abbokinase this summer, but later pushed back the expected approval date to the third quarter (³ (Also see "Abbott Will Outlicense Ketolide Antibiotic, Focus On Quinolone And D2E7" - Pink Sheet, 15 Jul, 2002.), p. 20). The drug will be relaunched within the week following approval at a price similar to the 1998 cost.

Abbokinase is expected to generate $20 mil. in sales in 2002; under a summer launch, the drug would have generated $50 mil. During an Oct. 9 conference call, Abbott expressed confidence that Abbokinase would receive quick uptake from physicians.

"I am relatively confident that we'll see a fairly rapid uptake of the product by those physicians who are used to it and rely on its safety profile," Abbott Medical Products President Richard Gonzalez said.