It has been a busy May. From working in the yard to transform it from looking like property on which Boo Radley might have a house to putting on panel discussions and layers of business travel to grading papers and posting final grades to end up this semester of teaching. I didn’t even get time for the Weekly Roundup last week – when lots happened – so I was determined to get it out this week and here it is. This week there were a spate of interesting approvals – so let’s round it up! Yee Hah!
But before I do, let me remind you that I will be doing a Webinar on Tuesday, May 21 at 12 Noon Eastern Time where I will be reviewing my data base on FDA Warning and Untitled Letters and comparing enforcement respecting digital versus non-digital communications vehicles. The Webinar is free and open and I will be going into more detail and discussing additional aspects beyond what was in my White Paper on the same topic from last month – so sign up here.
The Stamp of Approval was busy this week at FDA:
- First Companion Diagnostic to Detect Gene Mutation Associated with a Certain Type of Lung Cancer Approved - FDA announced early this week the approval of the cobas EGFR Mutation test which is a companion diagnostic test to be used in conjunction with an already approved drug. The test detects epidermal growth factor receptor (EGFR) which exist in approximately 10% of non-small cell lung cancers, the most common type of lung cancer. This type of diagnostic will provide valuable direction in determining which patients will benefit from which treatment.
- First Nimodipine Oral Solution Approved for Some Brain Hemorrhage Patients – Though approved on May 10, FDA issued a press release on May 14 about the approval of Nymalize oral solution to treat patients who have experienced a ruptured blood vessel in the brain. Previously this medication had only been available as a liquid filled gel capsule.
- Prostate Cancer Drug Approved – A new drug for those fighting advanced prostate cancer was approved by FDA this week called Xofigo (radium Ra 223 dichloride) three months ahead of the PDUFA date under a priority review. Xofigo is intended for use in men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. It is the second prostate cancer treatment approved this year.
- Simponi is Approved for Ulcertative Colitis - FDA approved Simponi (golimumab) injection to treat moderate to severe ulcerative colitis in adults with moderate to severe US that is resistant to prior treatment or which requires continuous steroid therapy. Simponi works by blocking tumor necrosis factor (TNF). Simponi is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
That’s it for me this week. Have a good weekend everyone. Come to the Webinar on Tuesday!