Lots on the FDA docket, approvals, delays, virtual meetings

Here is the medical news to watch for July 13-19, 2020.

Dermatology: The FDA was expected to make a decision on a topical treatment for molluscum contagiosum (Verrica Pharmaceuticals’ VP-102, cantharidin 0.7%) by July 13, but it is likely that the FDA will either extend the PDUFA date or issue a complete response letter because the FDA in late June notified the company that there were “deficiencies” in the application.

Hematology: The International Society on Thrombosis and Haemostasis (ISTH) virtual meeting will continue through July 14. The meeting includes the latest science in coagulation, platelets, hemophilia, thromboembolism, and vascular biology. Among the data to watch are:

  • Updated safety results from the Phase IIIb STASEY trial and new results from the Phase III HAVEN-5 trial of emicizumab (Roche’s Hemlibra) in patients with hemophilia A.
  • Data from the initial dose cohorts of the Phase I/II trial of a gene therapy for hemophilia A (Roche/Spark Therapeutics’ SPK-8011).

Nephrology: On July 15 the FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet virtually to review a new treatment, a V1 receptor selective vasopressin analog (Mallinckrodt’s terlipressin), for hepatorenal syndrome type 1 (HRS-1), a life-threatening condition involving acute kidney failure in people with cirrhosis of the liver.

Neurology: The FDA is expected to make a decision by July 13 on expanded approval of a capsaicin patch (Averitas Pharma’s Qutenza) to include treatment of neuropathic pain from diabetic peripheral neuropathy.

Oncology: The FDA’s Oncologic Drugs Advisory Committee will hold a virtual review on July 14 of GlaxoSmithKline and Seattle Genetics’ belantamab mafodotin, an antibody-drug conjugate (ADC) for relapsed/refractory multiple myeloma.

Ophthalmology: The FDA is expected to make a decision by July 16 on approval of a treatment for acquired blepharoptosis – Osmotica Pharmaceuticals/Vertical Pharmaceuticals’ RVL-1201 (oxymetazoline hydrochloride ophthalmic solution).

Radiology: The Society of Nuclear Medicine & Molecular Imaging (SNMMI) virtual meeting is continuing through July 14.


  • The FDA and Duke-Margolis Center for Health Policy are hosting a virtual public meeting on July 13-14 to explore potential approaches to developing a high-quality real-world data (RWD) ecosystem. Under consideration will be technical challenges and cultural barriers to the scalability of data capture processes as well as emerging practices.
  • The FDA’s Center for Devices and Radiological Health (CDRH) is hosting another in its series of virtual town halls on July 15 for clinical laboratories and commercial manufacturers who are developing or have developed Covid-19 diagnostic tests.
  • The FDA and the American Society of Clinical Oncology (ASCO) are holding a virtual public workshop on July 17 on the use of patient-reported outcome (PRO) measures in cancer clinical trials. The specific goal of the meeting is to discuss creation of regulatory-grade PRO data on tolerability.

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

Cat ID: 150

Topic ID: 88,150,730,105,935,127,130,150,725,240,96