Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.

Two innovators in the concussion assessment space have advanced their products with new funding and new clearances. Brainscope Co. Inc. secured $35 million in capital through an intellectual property-based funding arrangement with Aon plc to expand access to and develop new applications for its EEG-based product. Syncthink Inc. received a second FDA clearance for its Eye-Sync platform for mild traumatic brain injury diagnosis.

Even though the U.S. already has a National Plan to Address Alzheimer’s Disease, a bipartisan group of U.S. senators is adding its voice to that of nearly 200 national organizations and experts in calling for more. In a recent letter to Health and Human Services (HHS) Secretary Xavier Becerra, the 15 senators requested that he make reducing the prevalence of dementias a departmental priority.

If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients.

The FDA reported two class I recalls associated with insulin pumps made by Dublin-based Medtronic plc, albeit for two significantly different issues. The two recalls affect roughly 495,000 units combined, and may significantly affect access to some patients. One of the recalls was for Minimed 600 series insulin pumps, a recall announced in 2019 and expanded in October. The recall addresses the risk of incorrect dosing of insulin due to a faulty clear retainer ring, which is used to lock the insulin cartridge into place in the insulin pump reservoir. The second recall is for remote controllers used with Medtronic insulin pumps. In this instance, the action was undertaken due to cybersecurity concerns, although the controllers in question are no longer in distribution.

Orthopedics device startup Amber Implants BV has received an FDA breakthrough designation for its cementless spinal implant Vcfix. The system is designed to treat vertebral compression fractures (VCFs), which can cause patients severe back pain and limited mobility. Currently, VCFs are treated with injection of bone cement into the vertebra.