FDA Pipeline preview, May 2008

Epysqli is a monoclonal antibody that is approved to treat two rare conditions that break down red blood cells.

Boehringer Ingelheim’s high- and low-concentration adalimumab-adbm will be available through GoodRx for $550 for two-pack, which represents a 92% discount from the Humira list price.

If approved, tabelecleucel would be the first therapy specifically to treat Epstein-Barr virus related post-transplant lymphoproliferative disease. The FDA’s action date is Jan. 15, 2025.

OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.

The switch to biosimilars helped Navitus clients offset increased utilization in the non-specialty category and the introduction of higher-cost specialty drugs.

Giant cell arteritis is an inflammatory disease that affects the large blood vessels that supply blood to the head and brain.