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Kaletra receives EU marketing approval; developing countries registration 'moving forward'
Edwin J. Bernard, Tuesday, July 04, 2006
The Meltrex tablet formulation of Kaletra (lopinavir/ritonavir) has now received full marketing approval from the European Medicines Agency (EMEA), according to a statement from the drug's manufacturer, Abbott, who says this now allows them to register the new formulation in countries eligible for its access programme, which offers the drug at a steeply discounted price in more than 60 least developed countries.

The main benefit of the new Kaletra tablet is that it does not need to be refrigerated. Previous studies have found that Kaletra capsules are likely to deteriorate rapidly in resource-limited settings with hot climates and need to be stored and dispensed with care.

Abbott's press release says that European Union (EU) "approval will complement Abbott's efforts to expedite registration filings for the tablet formulation in countries around the world, including in developing countries. To date, Abbott has filed for registration of the new tablet formulation in countries in Africa, Asia and Latin America. Many developing countries require documentation of European approval as part of the filing process for the new tablet formulation. Abbott will be obtaining the necessary documentation and moving forward with the filing process in these countries."

Abbott has previously been criticised by Médecins Sans Frontières for not expediting registration of the new tablet, which is urgently required for second-line treatment in developing countries. Abbott claimed that they required EU approval first, since the tablet is manufactured in Germany, and many African regulatory authorities require a certificate of pharmaceutical production from the EU. However, MSF disputes this explanation. Abbott has also said that it will offer the new tablet to least developed countries at a deeply discounted annual price of $500.

Other benefits of the new tablet include dosing with or without food and a reduced pill count for those on standard dosing (400mg lopinavir/100mg ritonavir) twice daily.

In the United States the orange gel capsule formulation was withdrawn within a few months of the tablet's approval, in order to avoid confusion between the two formulations. Abbott says that "the vast majority of patients will convert to the tablet formulation", but does not give a specific timeframe for this in Europe. They advise individuals currently on the gel capsule formulation to "finish taking their current supply before starting a new prescription", and that they "should never take Kaletra tablets and capsules together.

Individuals who require a non-standard dose of Kaletra - for example, two or four capsules twice-daily - and who are unable to switch to the new tablets will be able to remain on the capsules, at least for the moment. "Capsules will remain available in special cases where they are needed, including paediatrics," says Abbott.

Abbott told AIDS Treatment Update two months ago that it is committed to helping people who are on non-standard dosing, and are developing a half-dose tablet to replace the foul-tasting liquid Kaletra aimed at children - although this will not be available until at least the end of next year.

In addition, Abbott claims that manufacturing a similar Meltrex version of ritonavir (Norvir), which is used to boost rival drug companies' protease inhibitors, is proving even more complex than developing the Kaletra tablet, and that this will not be available any time soon.



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