There has been so much rain in the past week, it is difficult for those of us in Washington, D.C. to remember that we live in that Washington and not Washington state. It has been relentless and it continues. It has also been raining FDA -related actions this week, of which many blog posts could be written. But time, like the weather, is constraining so here is a bit of what happened in digest:
- Migraine Preventive Gets FDA OK – FDA announced approval of a new biologic therapy for the preventive treatment of migraine in adults. During clinical trials Aimovig (erenunab-aooe) was found to reduce the number of days migraines were suffered by patients in clinical trials. Aimovig works as a calcitonin gene-related peptide receptor (CGRP-R) thought to play a role in migraine. An interesting side note in the wake of the national discussion on pricing that took place this week, the release from the company names the list price for the drug, outlines a rationale for the price set and discusses the patient assistance program. The company press release can be found here and the multi-media news release here.
- FDA Approves New Treatment for Opioid Addiction – A priority of FDA and of the Commissioner has been to make new treatments available for opioid withdrawal symptoms. This week Lucemyra (lofexidine hydrochloride) the first non-opioid product was approved for use by FDA for the mitigation of withdrawal symptoms. Only approved for use for a fourteen day period, the release from FDA cautions that it may not prevent withdrawal symptoms but may lessen severity of symptoms and is not a treatment for opioid use disorder, but is part of a broader treatment plan. Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist reducing the release of nopinephrine which is believed to play a role in the symptoms. The treatment was granted priority review and fast track and will be required to engage in 15 postmarketing studies. On a related note, Commissioner Gottlieb posted on the FDA Voice blog an entry regarding actions and upcoming plans to address concerns that a balanced approach to the opioid misuse with respect to the needs of patients who require pain control.
- Trump Speech on Pharma Pricing and Aftermath – Technically last week, but continued into this week. The speech was to have been delivered in late April, was delayed, and then delivered on May 11. Despite the anticipation and build up to the speech by Administration officials, the actual speech resulted in a rise in pharma industry stocks. Nevertheless, there were follow up statements from HHS Secretary Azar as well as Commissioner Gottlieb, the latter of which seemed to set up the subsequent FDA unveiling of a portion of the website devoted to listing names of pharma companies where there have been reported issues related to access for purposes of generic drug development the subject of a posting yesterday). And in addition, the Administration posted the blueprint for action which was less a plan than it was a compilation of topics for discussion called American Patients First.
Things to Keep an Eye on This Week
- May 22 – Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee with Drug Safety and Risk Management Advisory Committee – consider NDA for buprenorphine sublingual spray for treatment of moderate to severe pain where an opioid analgesic is appropriate
- May 22 Senate HELP Committee Hearing – The Healthcare Workforce: Addressing Shortages and Improving Care
- May 23 Senate HELP Committee Hearing – S.2852 Pandemic and All-Hazards Preparedness Innovation Act of 2018
Regulatory Developments in Pharma/Biotech/Devices
- First biosimilar for epoetin alpha gets approval
- Expanded indication for Truvada in HIV
- Hemphilia-A study drug gets breakthrough therapy designation
- FDA proposes new rule in combination product regulation