Targeted alkali thermolysis (TAT) technology
Trade Name: Brella™ 3-miniute
Company: Candesant Biomedical
Approval Dates/Comments: In April 2023, the US FDA granted clearance to this single-use disposable patch to reduce excessive underarm sweating in adults with primary axillary hyperhidrosis (PAH). The product uses the company’s novel, patented TAT technology, which is based on the scientific principle of heat production when sodium comes in contact with water – the interaction generates a targeted amount of heat that triggers microthermal injury to the sweat gland, leading to temporary inactivation. Brella™ SweatControl Patch contains a sodium sheet with an adhesive overlay, whereby heat is generated when water in the sweat touches the sodium sheet. Treatment is administered in a doctor’s office and available by prescription only, with results lasting 3-4 months. The regulatory decision of Brella™ was based on the results of SAHARA, a randomized, double-blind, sham-controlled, multicenter clinical study in 110 adults with PAH. Subjects were given bilateral treatment with Brella™ or a sham patch for up to 3 minutes for each underarm; patients were evaluated weekly for 12 weeks post-treatment. The study met its primary and secondary endpoints, and the patch was well tolerated with no serious or severe adverse events reported.
Retifanlimab-dlwr for IV infusion
Trade Name: Zynyz™
Company: Incyte Corporation
Approval Dates/Comments: The FDA granted accelerated approval for retifanlimab-dlwr, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in March 2023 for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This regulatory decision was based on tumor response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory trials. Safety and efficacy were evaluated in PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 patients with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR). The ORR was 52% (95% CI: 40, 65) with complete response rate of 18%; 26 patients (76%) had a DOR ≥6 months and 21 (62%) had a DOR ≥12 months. The safety population consisted of 105 patients with MCC. The most common (≥10%) adverse reactions were fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea. Serious adverse reactions occurred in 22% of patients receiving retifanlimab.
Spesolimab IV for IV infusion
Trade Name: Spevigo®
Company: Boehringer Ingelheim
Approval Dates/Comments: Health Canada granted marketing authorization in March 2023 for spesolimab as first-in-class treatment for generalized pustular psoriasis (GPP) flares in adults. Spesolimab is a novel, humanized selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signalling pathway in the immune system shown to be involved in the pathogenesis of many autoinflammatory disorders, including GPP.
Trade Name: NTLA-2002
Company: Intellia Therapeutics
Approval Dates/Comments: In March 2023, the FDA granted Regenerative Medicine Advanced Therapy designation to NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is an in vivo CRISPR-based investigational therapy designed to inactivate the target gene, kallikrein B1 (KLKB1), to potentially prevent life-threatening attacks in people with HAE.