) -- Fans of FDA advisory panels have a riveting week of action ahead.
Starting Tuesday morning, outside experts invited by FDA will weigh the risks and benefits of three different drugs on three consecutive days. The recommendations that emerge from these FDA advisory panels will factor into the agency's approval decisions.
brings Gattex, a treatment for short bowel syndrome, in front of the Gastrointestinal Drugs Advisory Committee on Tuesday Oct. 16.
On Wednesday Oct. 17, the Endocrinologic and Metabolic Drugs Advisory Committee convenes for two days of hearings to review drugs aimed at helping patients with a rare genetic disorder that causes extremely high levels of cholesterol to accumulate in their blood.
The panel will review
(AEGR - Get Report)
lomitapide on Wednesday followed on Thursday by mipomersen, a drug developed by
and the Genzyme unit of
(SNY - Get Report)
I will be live-blogging all three FDA advisory panels with play-by-play and analysis in real time from the opening gavels all the way through the final votes. [You can sign up for email reminders for each panel below.]
Short bowel syndrome (SBS) is a chronic and disabling condition that strikes people, who for various reasons including Crohn's disease, have about 50% of their lower intestines surgically removed. A majority of patients can adapt to lead normal lives. A smaller group of SBS patients never recover full functionality of their lower intestines, and a result, must spend the rest of their lives attached to an intravenous parenteral nutrition bag that provides the liquid nutrients they need to survive.
Gattex is an analogue of GLP-2, a protein involved with intestinal growth and function. Administered via a shot under the skin, Gattex is designed to boost the ability of the intestine to absorb nutrients.
On Friday, NPS Pharma shares rose 19% to $10.86 due to a largely positive FDA review of Gattex released ahead of Tuesday's panel. The FDA appears to be concur with NPS Pharma that Gattex provides a clinically meaningful benefit for SBS patients. The agency also appears unconcerned about three cases of cancer reported in patients treated with Gattex.