Rx Product News: July 2021

Apremilast (Otezla)

Manufactured by Amgen

FDA officials have accepted the supplemental New Drug Application (sNDA) for apremilast (Otezla) and set a Prescription Drug User Fee Act date of December 19, 2021. The application is for the use of apremilast for the treatment of adults with mild to severe plaque psoriasis. It currently is approved for the treatment of moderate to severe plaque psoriasis in adult patients with active psoriatic arthritis, adults who are candidates for phototherapy or systemic therapy, and adults with oral ulcers associated with Behçet disease. The sNDA acceptance is supported by data from the phase 3 ADVANCE study (NCT03721172), which found a safety profile similar to previous studies.

Bigfoot Unity System

Manufactured by Bigfoot Biomedical

The FDA has granted clearance to
the Bigfoot Unity System, the first smart pen cap for insulin dosing. It is approved for use in patients with type 1 or 2 diabetes aged 12 years and older. The device may help improve insulin dosing, according to a company statement. The smart pen cap allows on-demand, physician-recommended insulin dose decision support. It also can be easily integrated with Abbott’s FreeStyle Libre 2 sensor and can provide users with alerts related to incidences of hypoglycemia.

Tadalafil, Finasteride (Tadfin)

Manufactured by Veru Inc

An FDA application for finasteride and tadalafil combination capsules (Tadfin) has been accepted for the treatment of patients with benign prostatic hyperplasia (BPH). The capsules combine 5 mg of the 5-alpha reductase inhibitor finasteride and 5 mg of the Phosphodiesterase-5 inhibitor tadalafil. The simultaneous administration of these 2 treatments is approved for treating the initial symptoms of BPH for up to 26 weeks. The new application is intended for patients who have lower urinary tract symptoms and restricted urinary stream because of an enlarged prostate, according to a statement.

Etrasimod (APD334)

Manufactured by Arena Pharmaceuticals

New research suggests that Etrasimod could be effective and safe in the treatment of atopic dermatitis because it changes sphingosine 1-phosphate receptor 1 (S1P1). Etrasimod is a once-daily, oral S1P1,4,5 modulator that being studied for the treatment of moderate to severe ulcerative colitis and other immune-mediated inflammatory conditions. In a phase 2, placebo-controlled, 12-week study (NCT04162769) of atopic dermatitis, 29.8% of patients receiving etrasimod 2 mg once daily achieved a validated Investigator Global Assessment score of 3 or more at week 12.