Rx Product News: January 2024

Pilocarpine Hydrochloride Ophthalmic Solution 0.4% (Qlosi)

From: Orasis Pharmaceuticals

The FDA has approved pilocarpine hydrochloride ophthalmic solution 0.4% for the management of presbyopia in adults. Pilocarpine hydrochloride ophthalmic solution is a preservative-free, lowdose eye drop. The formula has met efficacy, safety, and comfort outcomes. The drops should be administered once or twice daily as needed. They provide relief within 20 minutes and last up to 8 hours. The role of pilocarpine is to improve the near visual acuity by pupil modulation, leading to an increased ability to focus on nearby objects.

FOR MORE INFORMATION: orasis-pharma.com

Tenapanor (Xphozah)

From: Ardelyx, Inc

The FDA has approved tenapanor to treat adults with chronic kidney disease who are on dialysis as add-on therapy and did not respond to phosphate binders or are intolerant of any dose of a phosphate binder therapy. The tablet should be administered twice daily and has a mechanism of action to block phosphate absorption through its primary pathway. Firstin-class tenapanor hinders the sodium/hydrogen exchanger 3, reducing phosphate absorption throughout the paracellular pathway. The most common adverse effect was mild to moderate diarrhea.

FOR MORE INFORMATION: ardelyx.com

Zilucoplan (Zilbrysq)

From: UCB, Inc

The FDA has approved zilucoplan for the management of generalized myasthenia gravis in adult patients with antiacetylcholine receptor antibody–positive disease. The approval makes zilucoplan the first oncedaily, self-administered, and subcutaneous targeted peptide of the C5 inhibitor. Zilucoplan was reported to offer rapid, consistent, and statistically significant improvement within patients. The most common adverse reactions were upper respiratory tract infections, diarrhea, and injection site reactions.

FOR MORE INFORMATION: ucb.com

Bimekizumab-bkzx (Bimzelx)

From: UCB, Inc

The FDA has approved bimekizumab-bkzx for the management of moderate to severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy. Bimekizumab is the first and only approved treatment created with humanized monoclonal IgG1 antibody that potently and selectively neutralizes IL-7A and IL-17F, which are key cytokines driving inflammatory processes. In findings from a clinical trial, patients treated with bimekizumab achieved superior levels of skin clearance within week 16 of management. The most common adverse events were upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, and fatigue.

FOR MORE INFORMATION: ucb.com