fizer’s HIV medicine Selzentry (maraviroc) could significantly expand its market today to include treatment-naïve patients, if a US Food and Drug Administration panel takes heed of briefing documents posted on the agency’s website ahead of the meeting.
In the documents, FDA staffers wrote that the compound appears “safe and well tolerated” in this patient population. Its safety is also backed up by 7,592 patient years worth of data versus only 526 patient years at the time of initial US approval, they say.
Treatment effects were maintained through to 96 weeks in both the maraviroc and comparator arm – Bristol-Myers Squibb’s Sustiva (efavirenz) – for both viral load endpoints of less than 400 copies/mL and less than 50 copies/mL. However, the documents also note that “substantially more” patients discontinued treatment in the efavirenz arm, and there were also fewer malignancies and fewer cases of tuberculosis amongst patients taking Pfizer’s drug. There was also a “significant benefit” in the lipid profile of maraviroc receivers.
Overall, they say, maraviroc offers a positive benefit-risk to treatment-naïve patients.
Maraviroc is already approved for marketing in more than 60 countries for use in treatment-experienced patients infected with CCR5-tropic HIV-1; the compound was the first approved drug of its class, which works by binding to CCR5 receptors to prevent HIV from entering and infecting the cell.