Expected FDA approvals, virtual meetings, workshops and town halls

Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Allergy: The FDA is expected to make a decision by August 5 on a patch for peanut allergy in children — DBV Technologies’ Viaskin Peanut.

Emergency medicine: The FDA is expected to make a decision by August 8 (postponed from July 8) on a treatment for exertional heat stroke (EHS) — Eagle Pharmaceuticals’ Ryanodex (dantrolene sodium). The FDA rejected it in 2017, saying another trial would be needed. The company completed a new 41-patient trial and is trying again.

Ophthalmology: The Gene Therapy for Ophthalmic Disorders virtual meeting will take place August 5-6. The meeting will bring together the FDA and many of the companies working on development of an ophthalmic gene therapy to talk about the future of gene therapy for ophthalmic conditions.

Pain: The FDA is expected to make a decision by August 7 on a treatment for moderate-to-severe pain in hospitalized patients, Trevena’s Olinvo (oliceridine). The FDA rejected this intravenous opioid, a G-protein biased mu-opioid receptor (MOR) ligand, in 2018 over concerns with safety and the potential for abuse. With additional data, Trevena is hopeful it can get FDA approval on a second try.

Psychology: The American Psychological Association (APA) virtual meeting will take place August 6-8. Among the topics to be covered are the psychology of racism and hate, leadership in the time of crisis, and the psychological toll of Covid-19, as well as the latest scientific research.

Pulmonology

  • The American Thoracic Society (ATS) virtual meeting will take place August 5-10. The program includes case-based presentations, the results of clinical trials in infectious diseases, late-breaking data, Covid-19, and more.
  • The FDA is expected to make a decision by August 5 on expanded approval for GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate + umeclidinium + vilanterol), a once daily, single-inhaler triple therapy, to include treatment of uncontrolled asthma. It is already approved to treat chronic obstructive pulmonary disease (COPD).

Regulatory

  • On August 4 the FDA is holding a virtual public workshop on development of new drugs to treat infections due to invasive molds and Candida auris.
  • On August 5 the FDA is holding another public workshop on development of antifungal drugs to treat Valley Fever (coccidioidomycosis).
  • On August 5 the FDA is also hosting yet another virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2, the virus that causes Covid-19.

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 725

Topic ID: 88,725,254,393,99,146,725,195,199,240