EMEA recommend approval for atazanavir for treatment experienced patients

On 20 November 2003 the Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion recommending a marketing authorisation for atazanavir 100mg, 150mg, 200mg and 50mg/1.5g hard capsules and oral powder for treatment of antiretroviral experienced adults. Marketing authorisation is expected to follow within 90 days, in early 2004.

The CPMP summary opinion lists benefits of atazanavir as “its once-daily dosing, the low risk of dyslipideamia and the good gastro-intestinal tolerance in comparison to lopinavir/r”. The opinion also recommends atazanavir be used at a dose of 300mg and boosted by 100mg ritonavir, although only limited data was available on this combination. Atazanavir was originally studied in treatment naïve patients at a dose of 400mg daily, without ritonavir boosting.

Comment

In practice, once a drug is licensed and available even with a limited indication, individual doctors have flexibility to use it in any patient who they believe would benefit from that treatment. Given the US approval of atazanavir for both naïve and experienced patients, there are certainly supportive data for this.

A similar example was set with the original EMEA approval of tenofovir. US approval had included both experienced and naïve patients, while the European indication for treatment naïve patients only followed assessment of 96-week data. Tenofovir was widely used off-label for first line therapy prior to this decision and is now recommended as such in guidelines.