FDA clears Boehringer’s once-daily HIV pill

The US Food and Drug Administration (FDA) has granted marketing approval for Boehringer Ingelheim's Viramune XR (nevirapine) extended-release tablets, a one-pill, once-daily formulation of the company's HIV drug Viramune, which was approved by the FDA in 1996 and is losing patent protection this year.

The extended-release formula has been cleared for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Boehringer is encouraging physicians to switch their patients to Viramune XR from the original version of the drug, an immediate-release pill that is taken twice daily and has now been approved by the FDA in much less expensive generic versions.

Boehringer said it has created a Viramune XR Co-Pay Savings Card to reduce the out-of-pocket cost of the new product to patients. The card, which is available to eligible patients for up to one year, will pay for the initial co-pay and up to $100 off each monthly prescription. The company noted that it has also expanded its Virology Patient Assistance programme to allow more patients to qualify to receive its medicines for free in the US.

The Viramune XR approval was based on a phase III study showing that the extended-release product achieved a virologic response that was as strong as the original formulation through 48 weeks and had a similar safety and tolerability profile. Both formulations were administered in the study in combination with Gilead's Truvada (emtricitabine and tenofovir disoproxil fumarate).