New FDA reviews, decisions on deck; virtual meetings continue

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

Here is the medical news to watch for Nov. 2-8, 2020. Be sure to vote.

Anesthesiology: The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet jointly with the Drug Safety and Risk Management Advisory Committee on Nov. 2 for a virtual review of Õlas Pharma’s Hydexor (hydrocodone + acetaminophen + promethazine) for acute post-operative pain.

Neurology

  • The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet virtually on Nov. 6 to review Biogen and Eisai’s aducanumab, an amyloid beta antibody, for Alzheimer’s disease. Remember, the pivotal trial failed, but the company submitted the drug to the FDA based on a post hoc analysis in a subgroup of patients.
  • The FDA is expected to make a decision by Nov. 8 on a non-addictive (and non-scheduled) treatment for attention-deficit/hyperactivity disorder (ADHD), Supernus Pharmaceuticals’ viloxazine (SPN-812), an oral serotonin norepinephrine modulating agent (SNMA).
  • The Clinical Trials on Alzheimer’s Disease (CTAD) virtual meeting will take place Nov. 4-7. Among the drugs in development to treat Alzheimer’s that will have data at the meeting are:
    • The Phase II/III GAIN trial of a gingipain inhibitor (Cortexyme’s atuzaginstat, COR-388).
    • A Phase II trial of an anti-tau antibody, AbbVie’s tilavonemab (ABBV-8E12).
    • A preliminary analysis of the 12-month, open-label extension of the Phase IIb trial of another anti-amyloid beta, Eisai and Biogen’s BAN-2401, on brain amyloid and ARIA-E.
    • The pharmacology of a novel fully human anti-PD-L1 antibody, ImmunoBrain Checkpoint’s IBC-Ab002.
    • The details of the failed, 64-patient Phase IIb trial of Cassava Sciences’ sumifilam (PTI-125), a small molecule that binds to filamin A, in mild-to-moderate AD.

Rheumatology: The virtual American College of Rheumatology (ACR Convergence) meeting will take place Nov. 5-9. Among the topics that will be covered are racial disparity in rheumatoid arthritis and osteoarthritis, whether JAK inhibitors should be used before biologic agents, the mechanism responsible for the development of arthritic pain, the long-term safety of gout treatments, and much more. There will also be data to watch, including: the Phase III TULIP trials of AstraZeneca’s anifrolumab (MEDI-546), an IgG1k antibody, in moderate-to-severe systemic lupus erythematosus (SLE), looking at organ and skin effects, flare, and herpes zoster events.

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

Cat ID: 127

Topic ID: 81,127,663,730,127,192,725,234,925