Name/CompanyApproval Dates/Comments
Binimetinib + Encorafenib
Mektovi® + Braftovi®
Array BioPharma
In June 2018, the US FDA approved these kinase inhibitors indicated for oral combination treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a FDA-approved test. Binimetinib (a small molecule MEK inhibitor) + encorafenib (a small molecule BRAF inhibitor) in combination is the first targeted treatment to demonstrate over 30 months median overall survival in a Phase 3 trial.
Crisaborole 2% ointment
In June 2018, Health Canada approved crisaborole, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor, to treat mild-to-moderate eczema (atopic dermatitis, AD) in patients ≥2 years of age.
Glycopyrronium tosylate 2.4% cloth
The FDA approved glycopyrronium topical wipes in June 2018 for the treatment of primary axillary (underarm) hyperhidrosis in adult and pediatric patients ≥9 years of age. Qbrexza™ comes in single-use, pre-moistened, medicated cloths (or wipes) that are applied directly on the skin once daily. One wipe is intended to be used for two underarms. The treatment works by blocking receptors responsible for sweat gland activation.
Secukinumab for SC injection
In June 2018, the FDA approved new evidence that secukinumab, an interleukin-17A inhibitor, significantly slows the progression of joint structural damage at Week 24 versus placebo in patients with active psoriatic arthritis. The updated label will be added to the drug’s prescribing information and is effective in the US immediately.
Tecovirimat capsule
SIGA Technologies
In July 2018, the FDA approved tecovirimat, an orthopoxvirusspecific antiviral indicated for the treatment of human smallpox disease caused by the variola virus. This is the first approved treatment for smallpox, a disease that at one time was thought to have been eradicated, but due to the threat of bioterrorism has become a renewed global concern.
Diacerein 1% ointment
Castle Creek
In August 2018, the FDA designated as a Fast Track development program the investigation of diacerein 1% ointment (CCP-020) for the treatment of epidermolysis bullosa simplex (EBS). Diacerein is a slow-acting, small molecular weight compound of the class anthraquinone with potent anti-inflammatory properties. Diacerein and its active metabolite rhein have been shown to inhibit the in vitro and in vivo production and activity of IL-1β and other pro-inflammatory cytokines. By blocking the inflammatory signaling pathway associated with EBS, diacerin strengthens epidermal tissue and heals skin blisters.
Migalastat capsule
Amicus Therapeutics
In August 2018, the FDA approved migalastat, the first oral medication for treating Fabry disease. The drug is indicated for use in adults who have a genetic mutation determined to be responsive to therapy based on laboratory data. This first-in-class chaperone treatment is designed to restore alpha-gal A activity in patients with amenable mutations.
Mogamulizumabkpkc for IV use
Kyowa Hakko Kirin
The FDA approved mogamulizumab-kpkc in August 2018 for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome (two subtypes of cutaneous T-cell lymphoma [CTCL]) after at least one prior systemic therapy. Poteligeo® is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain blood cancers including CTCL.

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