FDA actions in brief, March 2008

Susvimo is also approved to treat diabetic macular edema and age-related macular degeneration, and the medication, ranibizumab, is delivered through an ocular implant that is refilled every nine months.

Health plan sponsors are also expected to see a reduction in the net cost per prescription of GLP-1 medications to treat obesity.

Bayer’s Jivi is a factor VIII replacement therapy that has been engineered with a compound that allows for less frequent dosing. It is now indicated for patients 7 years of age and older.

Zynyz is now FDA-approved as the first and only approved first line treatment for advanced squamous cell carcinoma of the anal canal.

A new law in Iowa, if signed by the governor, will mandate 100% pass-through of rebates, increased financial transparency, and a minimal payment for pharmacies. Critics say it will be the most costly mandate in the state’s history.

It could improve access to community pharmacies and lower prices. Or it will limit access to critical drugs and impact payers’ ability to contract for a broad range of services. Industry leaders are unsure about the impact of Arkansas’ law banning PBMs from owning pharmacies.