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Kaletra™ (ABT-378/r) Application for Accelerated Approval

June 23, 2000

On June 1 Abbott Laboratories announced that it had filed a New Drug Application with the U.S. FDA for accelerated approval of its new protease inhibitor, new brand name Kaletra (pronunciation Kuh Lee Truh) (generic name lopinavir/ritonavir, most widely known as ABT-378/r). Kaletra is a combination of ABT-378 with a low dose of ritonavir; the ritonavir is used to block a liver enzyme which would otherwise quickly metabolize lopinavir, keeping the blood level of lopinavir high. Kaletra is being tested at twice daily dosing (later it will also be tested once a day). Abbott plans to submit applications for approval in Europe in late June, and elsewhere later this year.

Kaletra, better known as ABT-378/r, has now been used in an early-access program by almost 3000 patients in the U.S., and over 1300 in other countries. In addition, a phase III trial in hundreds of adults, and another phase III trial in children, are ongoing. An early-access program for children is expected to open soon.


Comment

This drug normally maintains blood levels much higher than necessary to inhibit HIV, providing a safety margin and allowing inhibition of some partially resistant viruses. Resistance to Kaletra can develop; in many cases, however, these viruses are susceptible to saquinavir (Fortovase®). So far the safety profile looks good, with only two of 170 volunteers withdrawing from an earlier trial due to short-term side effects; however, it is too early to know about lipodystrophy and other long-term problems which have become increasingly serious with other antiretrovirals.

No price has been set, but there is widespread concern that Abbott may price this drug outside the range of current protease inhibitors, which would increase the overall cost of HIV care since Kaletra must still be used as part of a combination. Over 50 organizations have signed a "Consensus Statement on the Pricing of Enteric Coated ddI and ABT- 378," calling on "manufacturers to rethink their plans for pricing and to act as responsible citizens playing a key role in the fight against a worldwide epidemic." Abbott recently met with the Fair Price Working Group, which circulated the statement.

[Note: the text was published in AIDS TREATMENT NEWS #344 (June 2, 2000); you can read it at -- http://www.aids.org/immunet/atn.nsf/page/a-341-07. Over 245 individuals and organizations have signed so far. To endorse this statement, send your name, city, and state, and your organizational affiliation if it can be published, to the Fair Price Working Group at lgrinberg@aol.com.]

Persons with HIV who have failed previous protease-inhibitor treatments and have no other viable options may be eligible for the expanded access program for Kaletra. For more information about this program, U.S. patients and physicians can call 1-888-711-7193.

Note: To find Kaletra (ABT-378/r) information from the recent resistance conference, see "HIV Drug Resistance Meeting: Reports on Web," in this issue.



ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


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