It seems that the next two weeks would be quite busy for the U.S. Food and Drug Administration (FDA) as a series of target action dates have been scheduled. The FDA has scheduled approvals of three drug – two drugs for extra indications for already approved biologics, while the third drug is a combination treatment for glaucoma. Let’s take a look at those drugs:
Dupixent for Atopic Dermatitis
Regeneron Pharmaceuticals and Sanofi have a target action alert date schedule on Monday, March 11 for their sBLA (supplemental Biologics License Application) for a drug called Dupixent (dupilumab) in adolescents aging between 12 and 17 with moderate to severe atopic dermatitis (eczema), which was poorly controlled with topical applications or where topical treatment was not medically advisable.
There have been no current FDA-approved systemic biologics for adolescents with atopic dermatitis.
Dupixent suppresses the signaling of the interleukin-3 and interleukin-13. The signaling is responsible for causing inflammation, especially type 2 inflammation, which can be seen in moderate-to-severe atopic dermatitis.
Abraxane and Tecentriq for Breast Cancer
Celgene, which produces Abraxane (paclitaxel), has a target action date scheduled on Tuesday, March 12 for its sBLA filed by Roche’s Tecentriq (atezolizumab). The combination of Abraxane and Tecentriq is recommended for the treatment of metastatic breast cancer. Along with breast cancer, Abraxane has been already approved for advanced non-small cell lung cancer and metastatic pancreatic cancer.
In October 2018, Celgene and Roche announced promising results from the clinical trial of the two drugs for the initial treatment of metastatic breast cancer, decreasing the risk of the disease aggravation when compared with chemotherapy alone.
Roclatan for Glaucoma Aerie Pharmaceuticals has a target action date scheduled on Thursday, March 14 for its New Drug Application (NDA) for a medicine called Roclatan a combination of netarsudil and latanoprost, for glaucoma as well as ocular hypertension (OHT). Roclatan is an ophthalmic solution that can be used as a once-daily treatment. If approved by the FDA, Roclatan would be the first fixed-dose combination drug in the U.S.
