Weekly Roundup 9.19.14

Argh!  It is International Talk Like a Pirate Day! Fear not Matey!  I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder.

There were lots of approvals this week and finally a wee bit of action from the Office of Prescription Drug Promotion (OPDP) which so far this year has produced very little output in the way of warning or untitled letters.  The one sent out this month brings us to a grand total of 7 for the year, far below any rate of production recorded on these humble pages.

  • New Type 2 Diabetes Drug Approved FDA gave Lilly’s Trulicity (dulaglutide) a green light this week.  Trulicity is a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with Type 2 diabetes.  The drug is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels and comes with a Boxed Warning regarding an increased risk for thyroid C-cell tumors based on studies in rats. FDA will be looking for some post-marketing studies for the compound – studies in pediatric patients on efficacy and safety as well as others.  According to the company release, Lilly plans to make Trulicity available in single dose pens in two doses.
  • Treatment for Opioid-Induced Constipation Approved – A common side effect faced by patients using opioids to control pain is constipation as the drugs reduce the motility of the gastrointestinal tract. This week the agency approved a new oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.  According to FDA’s release, the results of the trials measured two doses – 25 mg and 12.5 mg – and found that 44 percent of study participants at the first dose and 41` percent at the second dose experienced an increase in bowel movements compared to 29 percent who were on placebo.  The agency is looking for a postmarketing study related to cardiovascular adverse events.  The company said it expects to have the drug available to patients during the first half of 2015.
  • AdComm Vote on Testosterone Replacement Therapy Candidate – A joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met this week to consider approval of Testosterone Undecanoate – brand name REXTORO, put forward for consideration by Clarus Therapeutics.  The committee against the overall risk/benefit ratio by a large margin.  As is well-known, FDA is not required to follow the recommendation of the advisory committee.

That’s it for me today, matey.  To celebrate the day, I’ll be having a nice seafood lunch!  Argh!

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