Paediatric lopinavir/r receives positive opinion from EMEA
On 28 January, 2008 Abbott announced that the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of a new, lower-strength tablet formulation of lopinavir/r (Kaletra,). The CHMP also adopted a positive opinion, in coordination with the World Health Organization (WHO), for the same lower-strength formulation in developing countries (trade name Aluvia).
The new lower-strength formulation is suitable for pediatric use.
The European Commission will review the CHMPs positive opinion for Kaletra and is expected to issue a final decision for marketing authorisation for the lower-strength Kaletra in the European Union within the next 60-90 days.
The price of the lower-strength tablet will be half the price of the original-strength tablet everywhere it is available.
Based on the U.S. Food and Drug Administration (FDA) approval on November 9, 2007, the paediatric dose of lopinavir/r can already be exported to countries such as Uganda is their government approves a waiver.
The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its approval in September 2000 in the United States. For pediatric patients,
Lower-strength Kaletra tablets will offer more dosing flexibility and contain 100mg of lopinavir and 25mg of ritonavir (compared with the original tablet strength of 200mg of lopinavir and 50mg of ritonavir). The oral solution used in paediatric care will continue to be available.
Source: Abbott press release Abbotts Kaletra® and Aluvia® (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA. 28 January 2008.