Abbott’s new tablet formulation of Kaletra (lopinavir/ritonavir) has received a positive opinion from the scientific committee of the European Medicines Agency (EMEA), the company announced today, and should receive marketing approval within three months. Abbott says that the approval allows it to go ahead to file for registration in developing countries.
The new tablet formulation of Kaletra, already approved in the United States, will reduce the daily pill burden for patients from three capsules twice daily to two tablets twice daily. Patients taking the drug once a day will need to take only four tablets. The tablet version does not need to be taken with food, and does not need to be refrigerated, making it particularly attractive as a second-line protease inhibitor in hot climates.
Abbott has been criticised by Medecins Sans Frontieres (MSF) for being slow to register the new formulation in Africa, where it has promised a reduced price of $500 a year for the new formulation. Abbott says that it has been waiting for European approval, since many African regulatory authorities require a certificate of pharmaceutical production from the European Union because the drug is manufactured in Germany.
MSF disputes this explanation, saying that Abbott could choose to export the drug from the United States, allowing quicker registration.
“We see this again and again: drug companies make an announcement about a special price but don’t register the drug in eligible countries, so the price remains virtual and the announcement is meaningless for patients in need of these medicines,” said Dr Rowan Gillies, International President of MSF yesterday in a statement.
Abbott said last month that it has submitted the new formulation of Kaletra for registration in South Africa, and has been granted a fast track review by the South African Medicines Control Council. However, the company was criticised again yesterday by MSF; the international medical charity claims that Abbott has still to fill an order for the medicine for 400 MSF patients in nine countries that MSF placed over one month ago on March 15th, 2006.