By Ted Rosen
RUXOLITINIB 1.5% CREAM (Opzelura, Incyte Dermatology) is already approved for the treatment of mild to moderate atopic dermatitis. The FDA has accepted a priority supplemental New Drug Application (sNDA) for the same agent for use in vitiligo. This is based on the results of two phase 3 trials where twice daily application of ruxolitinib 1.5% cream resulted in 29.9% of subjects experiencing at least a 75% improvement in facial vitiligo.
The FDA expanded the label on POLY-L-LACTIC ACID INJECTABLE FILLER (Sculptra, Galderma). The new label includes higher dilution, an addition of immediate use reconstitution, new injection techniques, and the option to add lidocaine.
The FDA approved PEMBROLIZUMAB (Keytruda, Merck) as adjuvant therapy for adults and children aged 12 years or older with stage IIB or IIC melanoma following complete resection. The approval was based on a trial comparing pembrolizumab 200mg (2mg/kg for ages 12 to 17) every three weeks for one year with placebo. After median follow-up of 14.4 months, 11% of patients in the pembrolizumab group experienced recurrence or died compared to 17% of patients in the placebo group.
The FDA approved UPADACITINIB 15MG (Rinvoq, Abbvie) as a once daily oral agent for the treatment of active psoriatic arthritis in patients who have had intolerance or inadequate response to TNF-alfa inhibitors. Oral upadacitinib improves function, reduces pain and prevents radiologic progression of psoriatic arthritis based upon the results of two parallel phase 3 trials.
The FDA approved UPADACITINIB (Rinvoq, Abbvie) 15mg or 30mg as a once daily oral agent for the treatment of adults and children 12 years and older with refractory, moderate to severe atopic dermatitis. Upadacitinib provided significant improvement in itch (Worst Pruritus Numerical Rating Scale (NRS) ≥4) as early as week one, as well as significant improvements in skin clearance (Eczema Area and Severity Index (EASI) 75, EASI 90, EASI 100 and IGA of clear or almost clear) at 16 weeks, compared to placebo.
The FDA approved ABROCITINIB (Cibinqo, Pfizer) 100mg or 200mg as a once daily oral agent for the treatment of adults with refractory, moderate to severe atopic dermatitis. Abrocitinib provided significant improvement in itch (Worst Pruritus NRS ≥4) as early as week two, as well as significant improvements in skin clearance (EASI 75 and Investigator Global Assessment (IGA) of clear or almost clear) at 12 weeks, compared to placebo.
The FDA approved expansion of the indication for use of RIZANKIZUMAB-RZAA (Skyrizi, Abbvie) to include treatment of active psoriatic arthritis. The approval was based on data from two randomized, double-blind placebo-controlled pivotal studies, in which 57.3% and 51.3% of rizankizumab-treated patients achieved American College of Rheumatology 20 (ACR20) at week 24, compared with 34% and 27% of those who received placebo. Patients with enthesitis and dactylitis improved as well, and the side effect profile was similar to that seen in patients receiving this drug for moderate to severe plaque psoriasis.
The FDA approved CORTROPHIN GEL (purified adrenocorticotropic hormone or ACTH, Ani Pharmaceuticals) for intramuscular or subcutaneous injection for short-term adjunctive therapy for acute exacerbations of psoriasis and psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, sarcoidosis, erythema multiforme, and atopic dermatitis. This drug now re-enters the U.S. market. It was last available in the 1980s.
The FDA granted accelerated approval to VOXELOTOR (Oxbryta, GBT) tablets for the treatment of children aged 4 to 11 years with sickle cell disease, expanding the approved age of use from 12 years and older. Voxelotor is a once daily oral agent which directly inhibits sickle hemoglobin polymerization, thereby restoring the normal shape to red blood cells. This avoids complications related to reduced blood flow, such as sickle cell leg ulcers.
The FDA expanded the approved indication for APREMILAST (Otezla, Amgen) to include mild to moderate psoriasis. Previously, the drug was only approved for moderate to severe psoriasis.
The FDA approved extended release CABOTEGRAVIR and RILPIVIRINE (Cabenuva, ViiV Healthcare) injection for every two month dosing for the management of stable HIV infection based on the results of a 48-week study involving 1045 adults. The rate of virological suppression was 94.3% which compared favorably with the rate of virological suppression (93.5%) when the same drug is administered monthly.
The FDA granted breakthrough designation to STRANDDX-ASD (Linus Biotechnology), a biomedical device that identifies novel biomarkers from a single strand of hair which have a high correlation with the diagnosis of autism spectrum disorders.
