FDA Actions in Brief September 2012

Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.

Ojemda will have a wholesale acquisition cost of $33,916 for a 28 day supply and will be distributed through specialty pharmacies Biologics by McKesson and Onco360.

Lutathera is a radiotherapeutic that is now approved for patients 12 years and older neuroendocrine tumors in the pancreas or gastrointestinal tract.

ImmunityBio’s Anktiva is an antibody cytokine fusion protein approved to treat patients with non-muscle invasive bladder cancer.

Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.

Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.